On February 8, 2024 Foghorn Therapeutics presented its corporate presentation (Presentation, Foghorn Therapeutics, FEB 8, 2024, View Source [SID1234639938]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On February 8, 2024 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported its business update and financial results for the quarter ended December 31, 2023 (Press release, Curis, FEB 8, 2024, View Source [SID1234639937]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Operational Highlights

In December at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH) (Free ASH Whitepaper), the Company presented data from both the TakeAim Lymphoma and TakeAim Leukemia studies. A summary of key findings of the data that were presented from the on-going studies are as follows:

TakeAim Lymphoma – data for patients with primary CNS lymphoma (PCNSL) who had failed prior BTKi therapy showed 3 of 5 evaluable patients achieved Complete Response (CR).
TakeAim Leukemia – data for patients with relapsed/refractory (R/R) AML with a FLT3 mutation who received < 3 prior lines of treatment showed 2 of 3 patients achieved CR and the 3rd patient achieved Morphological Leukemia Free State (MLFS).
In addition to the presentations at ASH (Free ASH Whitepaper), Curis announced in December that it had entered into an agreement for an Investigator-Initiated Trial to study the combination of emavusertib and pembrolizumab in patients with metastatic melanoma. In this study, Curis will be responsible for the supply of emavusertib and Merck will be responsible for the supply of pembrolizumab and clinical study costs.

"The R/R PCNSL data presented at ASH (Free ASH Whitepaper) highlight the potential of emavusertib in combination with ibrutinib to address a critical unmet need, for a patient population with no approved treatments, and achieve CR in patients who have failed prior BTKi therapy. The R/R AML FLT3 data highlight emavusertib’s potential to provide targeted anti-cancer activity as a monotherapy. We have also begun working with clinical investigators to initiate a Phase 1 clinical study of emavusertib as an add-on agent to the combination of azacitidine and venetoclax in the front-line setting. Finally, the study evaluating emavusertib and pembrolizumab in metastatic melanoma will explore the potential of emavusertib and IRAK4 inhibition in solid tumors," said James Dentzer, President and Chief Executive Officer of Curis. "We are encouraged by the reaction of the clinical community to the data released at ASH (Free ASH Whitepaper) and are working to open additional clinical sites in the US and Europe for both the TakeAim Leukemia and Lymphoma studies."

Upcoming Milestones

TakeAim Leukemia – updated clinical data from the on-going monotherapy study in the first half of 2024.
TakeAim Lymphoma – updated clinical data from the on-going combination study of emavusertib with ibrutinib in the second half of 2024.
Curis expects initial clinical data from the recently initiated triplet combination study of emavusertib with azacitidine and venetoclax to treat AML patients in the second half of 2024.
Fourth Quarter 2023 Financial Results

For the year ended December 31, 2023, Curis reported a net loss of $47.4 million, or $8.96 per share on both a basic and diluted basis, as compared to a net loss of $56.7 million, or $12.14 per share on both a basic and diluted basis in 2022. For the fourth quarter of 2023, Curis reported a net loss of $11.7 million or $2.03 per share on both a basic and diluted basis as compared to a net loss of $11.3 million or $2.35 per share on both a basic and diluted basis for the same period in 2022.

Revenues, net for the year ended December 31, 2023, were $10.0 million as compared to $10.2 million for the same period in 2022. Revenues for both periods comprise primarily royalty revenues related to Genentech and Roche’s net sales of Erivedge. Revenues for the fourth quarters of 2023 and 2022 were $2.7 million and $2.9 million, respectively.

Cost of royalties, which relate to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, for the year ended December 31, 2023, were $0.2 million compared to $0.3 million for the same period in 2022. Cost of royalties for the fourth quarters of 2023 and 2022 were $0.1 million for both periods.

Research and development expenses were $39.5 million for the year ended December 31, 2023, as compared to $43.3 million for the same period in 2022. The decrease was primarily attributable to lower employee-related costs due to reduced headcount. Research and development expenses were $10.0 million and $8.7 million for the fourth quarters of 2023 and 2022, respectively.

General and administrative expenses were $18.6 million for the year ended December 31, 2023, as compared to $19.6 million for the same period in 2022. The decrease was primarily attributable to lower employee-related costs due to reduced headcount. General and administrative expenses were $4.9 million and $4.3 million for the fourth quarters of 2023 and 2022, respectively.

Other income, net was $0.9 million for the year ended December 31, 2023, as compared to other expense, net of $3.7 million for the same period in 2022. The increase was attributable to an increase in interest income and a decrease in the non-cash expense related to the sale of future royalties. Other income, net was $0.5 million for the fourth quarter of 2023 as compared to other expense, net of $1.1 million for the same period in 2022.

As of December 31, 2023, Curis’s cash, cash equivalents and investments totaled $56.3 million, and the Company had approximately 5.9 million shares of common stock outstanding. Curis expects its existing cash, cash equivalents and investments should enable its planned operations into 2025.

Conference Call Information

Curis management will host a conference call today, February 8, 2024, at 8:30 a.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 8:30 a.m. ET. The conference call can also be accessed on the Curis website in the Investors section.

On February 8, 2024 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for soquelitinib for the treatment of T cell lymphoma (Press release, Corvus Pharmaceuticals, FEB 8, 2024, View Source [SID1234639936]). Soquelitinib, the Company’s lead ITK inhibitor candidate, is expected to advance into a Phase 3 registrational clinical trial in patients with relapsed peripheral T cell lymphoma (PTCL) in the second quarter 2024.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Peripheral T cell lymphoma is an aggressive subset of non-Hodgkin’s lymphoma typically associated with a poor prognosis," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "For these patients, there is significant need for new therapies given that existing drugs provide limited efficacy and are associated with significant toxicity. There are no FDA approved agents for relapsed PTCL. The orphan drug designation is an important milestone in the development of soquelitinib that reinforces the unmet need for patients with T cell lymphoma."

FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.

On February 8, 2024 BioNTech SE (Nasdaq: BNTX, "BioNTech"), a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, and Autolus Therapeutics plc (Nasdaq: AUTL, "Autolus"), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported a strategic collaboration aimed at advancing both companies’ autologous CAR-T programs towards commercialization, pending regulatory authorizations (Press release, Autolus, FEB 8, 2024, View Source [SID1234639935]). In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The collaboration with Autolus enables us to expand our BNT211 program into trials for multiple cancer indications in a cost-efficient way. Autolus’ state-of-the-art manufacturing facilities’ set-up for clinical and commercial supply will enhance our own capacities in addition to our existing U.S. supply network and the ongoing expansion of our site in Gaithersburg, Maryland," said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. "Furthermore, this collaboration grants us access to Autolus’ precise cell targeting tools to further support BioNTech’s development of in vivo cell therapy and antibody-drug conjugate candidates."

"We see a remarkable opportunity to leverage our core capabilities, accelerate pipeline programs, realize cost-efficiencies and expand opportunities beyond autologous cell therapies," said Dr. Christian Itin, Chief Executive Officer of Autolus. "We look forward to investing a portion of the capital raised on delivering on obe-cel’s path in adult acute lymphoblastic leukaemia, potentially offering another treatment option for patients where there is still an unmet medical need. This collaboration creates a path for accelerating our respective oncology pipeline programs and broadening the use of Autolus’ technology outside of autologous cell therapy applications."

BioNTech has agreed to purchase $200 million of Autolus’ American Depositary Shares in a private placement. BioNTech will have a right to appoint a director to the Board of Autolus.

Under the terms of the license and option agreement, BioNTech will make a cash payment of $50 million and is granted the following rights in exchange:

•
BioNTech is eligible to receive an up to mid-single digit royalty on obe-cel net sales. Autolus will retain full rights to and control of the development and commercialization of obe-cel.

•
BioNTech has the option to access Autolus’ commercial and clinical site network, manufacturing capacities in the United Kingdom and commercial supply infrastructure in a cost-efficient set-up in order to accelerate the development of BNT211 in additional CLDN6+ tumor types. BioNTech plans to have 10 or more ongoing potentially registrational clinical trials in the pipeline by the end of 2024, including its fully owned CLDN6 CAR-T program BNT211 in relapsed or refractory germ cell tumors.

•
Autolus will lead the development and commercialization for AUTO1/22 and AUTO6NG in any oncology indication with BioNTech having an option to support certain development activities and co-commercialize both candidates in certain territories. If BioNTech exercises an option, it will receive a profit share with respect to such exercised product candidate worldwide while Autolus will be eligible to receive an option exercise fee, milestone payments and co-funding of development expenses.

•
Autolus granted BioNTech an exclusive license to develop and commercialize therapeutics incorporating certain of Autolus’ proprietary binders along with options to license binders and cell programming technology for use in BioNTech’s in vivo cell therapy development programs and investigational antibody-drug conjugates. If BioNTech exercises an option, Autolus will be eligible to receive exercise fees and milestones payments, with low-single digit royalties on net sales of the licensed products.

Evercore, goetzpartners and Cooley LLP acted as advisors to Autolus.

On February 8, 2024 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, reported consolidated financial results for its first fiscal quarter ended December 31, 2023. The Company’s Form 10-Q can be viewed at View Sourcesec-filings/" target="_blank" title="View Sourcesec-filings/" rel="nofollow">View Source (Press release, Applied DNA Sciences, FEB 8, 2024, View Source [SID1234639934]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We made substantial progress in advancing the commercialization of our Linea IVT platform and the availability of GMP capacity for the manufacture of critical starting material for mRNA therapeutics during the past quarter," stated Dr. James A. Hayward, president and CEO of Applied DNA. "Our efforts centered on establishing and implementing new quality systems for GMP manufacturing to meet our customer requirements at a scale sufficient for use through clinical-stage mRNA therapy development. In addition, we initiated a scale-up manufacturing project for our Linea RNA polymerase (RNAP) with an enzyme manufacturer to optimize the enzyme’s production for commercial-scale use. We also secured our first CDMO partner to validate the commercial scale-up of Linea IVT within a cGMP workflow setting.

"In parallel, we expanded our sales pipeline and active projects with the addition of new research and development-stage customers for Linea IVT that can serve as the basis for potential long-term supply agreements as customers’ therapies enter toxicology, pharmacokinetics, and early-stage clinical development," continued Dr. Hayward. "We generated data readouts that further substantiate the capacity of Linea IVT to create equal or greater RNA yields with double-stranded RNA contamination at levels 10x-50x lower than those found using conventional mRNA production methods. Feedback to-date on our Linea IVT and Linea DNA platforms has been positive, having completed multiple successful customer evaluations within the quarter. Particularly noteworthy, we completed an evaluation with a clinical stage mRNA customer in which our IVT templates meet or exceeded all customer quality metrics with manufacturing speed that exceeded all other IVT template sources being evaluated by the customer.

1Based on company internal modeling utilizing current pricing projections and industry figures

2 Linea IVT revenue is comprised of Linea DNA IVT templates, Linea RNAP and technology license royalty

Concluded Dr. Hayward, "Supplying both DNA template and RNA polymerase positions us to capture a greater percentage of the economics of mRNA therapy production that we believe establishing our GMP production capacity will unlock. After the close of the quarter, we completed an equity offering that supports the initial phase of our GMP plan and timeline for critical starting materials in the production of mRNA. Slated to come online during first half of calendar 2024 and based on internal modeling, current pricing projections, and industry figures, we project our GMP facility, with an initial footprint of less than 1,000 square feet, to enable annual total Linea IVT revenues of up to $15 million. We believe our manufacturing workflow is highly reproducible, allowing us to scale our production facilities to meet incremental customer demand quickly. Looking ahead, we will continue to prioritize the commercialization of our Linea IVT and Linea DNA platforms and rationalize our cost structure in support of our biotherapeutic goals."

Summary First Quarter Fiscal 2024 Financial Results:

· Total revenues were approximately $891 thousand for the three-month period December 31, 2023, compared to $5.3 million for the same period in the prior fiscal year. The decrease in revenue of approximately $4.4 million was due to an expected decline in COVID-19 testing services revenue of $4.2 million driven primarily by cancelation of the testing contract with City University of New York (CUNY) in June 2023. The decrease was also due to a reduction in product revenue of $209 thousand primarily related to a decline year-over-year in cotton DNA tagging revenue in our DNA Tagging and Security Products and Services segment.

· Gross profit for the three-month period ended December 31, 2023, was $231 thousand, compared to $2.4 million for the three-month period ended December 31, 2022. The gross profit percentage was 26% and 45% for the three-month periods ended December 31, 2023, and 2022, respectively. The decline in gross profit percentage was primarily the result of a decline in gross profit percentage for our MDx (Molecular Diagnostics) testing services segment specifically related to decreased COVID-19 testing volumes year over year. To a lesser extent, the decline in gross profit percentage was due to lower product revenues during the three-month period ended December 31, 2023, as compared to the same period in the prior fiscal year. The lower volume of product revenues in the current period were not able to fully absorb the fixed costs that are included in cost of product revenues.

· Operating expenses increased to $4.0 million for the three-month period ended December 31, 2023, as compared to $3.6 million for the first quarter of fiscal 2023. The increase in operating expenses is the result of an increase in selling, general and administrative expenses of approximately $459 thousand. The increase in SG&A expenses relates to the prior three-month period having a credit in bad debt expense of approximately $290 thousand, from a customer balance that was fully reserved and was subsequently collected during the three-month period ended December 31, 2023. The remainder of the increase is attributable to an increase in stock-based compensation expense of $247 thousand. The increase in stock-based compensation expense primarily relates to the timing of the annual non-employee board of director grant that vests one-year from the date of grant during the second quarter of fiscal 2023. These increases were offset by a decrease in payroll of approximately $107 thousand.

· Loss from operations was $3.8 million for the three-month period ended December 31, 2023, compared to $1.2 million for the first quarter of 2023.

· Excluding non-cash expenses, Adjusted EBITDA was a negative $3.2 million for the three-month period ended December 31, 2023, compared to a negative $1.1 million for the same period in fiscal 2023.

· Cash and cash equivalents stood at $3.4 million on December 31, 2023, compared with $7.2 million as of September 30, 2023.

On February 2, 2024, the Company closed on a registered direct offering with institutional investors for gross proceeds of $3.44 million. In a concurrent private placement, the Company issued 11,288,122 unregistered warrants with an exercise price of $0.609 per warrant share. If these warrants were to be exercised assuming stockholder approval is obtained, it would result in additional gross proceeds of $6.87 million. The Company also agreed to reduce the exercise price of warrants previously issued to the investors as well as other certain other prior investors with exercise prices ranging from $1.29 to $4.00 per warrant to $0.609 per warrant. The Company further agreed to extend the expiration dates for such warrants to August 2028. The foregoing reductions of the exercise price and extension of expiration dates of such warrants is subject to stockholder approval and if such warrants were to be exercised, it would result in additional gross proceeds of $1.86 million.

First Quarter Fiscal 2024 Conference Call Information

The Company will hold a conference call and webcast to discuss its first quarter of fiscal year 2024 financial results on Thursday, February 8, 2024, at 4:30 PM ET. To participate in the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, not all questions may be answered.

To Participate, please ask to be joined to the ‘Applied DNA Sciences’ call:

· Domestic callers (toll free): 844-887-9402

· International callers: 412-317-6798

· Canadian callers (toll free): 866-605-3852

Live and replay of webcast: View Source

Telephonic replay (available 1 hour following the conclusion of the live call through February 15, 2024):

· Domestic callers (toll free): 1-877-344-7529

· Canadian callers (toll free): 1-855-669-9658

· Participant Passcode: 3086410

An accompanying slide presentation that will be embedded in the webcast can be accessed under ‘News & Events’ tab and ‘Company Events’ section of the Applied DNA investor relations website at View Source

About the Linea DNA and Linea IVT Platforms

The Linea DNA platform is a completely cell-free DNA production platform founded on the Company’s long-standing expertise in the large-scale enzymatic production of DNA. Capable of producing DNA in quantities ranging from milligrams to grams, the Linea DNA platform can produce high-fidelity DNA constructs ranging from 100bp to 20kb in size. The DNA produced via the Linea DNA platform is free of the adventitious DNA sequences found in other sources of DNA, is rapidly scalable, and provides for simple chemical modification of DNA constructs.

The Linea IVT platform combines DNA IVT templates manufacturing via the Linea DNA platform with a proprietary Linea RNAP to enable mRNA and saRNA manufacturers to produce better mRNA faster, with advantages over conventional mRNA production, including: 1) the elimination of plasmid DNA as a starting material; 2) the prevention or reduction of dsRNA contamination; and 3) simplified mRNA production workflows.