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.

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"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.

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"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:

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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.

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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.

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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.

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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]).

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"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.

On February 8, 2024 Alligator Bioscience AB reported full year financial results for 2023 and for Q4 2023 and provides a business update (Press release, Alligator Bioscience, FEB 8, 2024, View Source [SID1234639933]).

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"Over the last 12 months our OPTIMIZE-1 trial evaluating our lead asset mitazalimab in pancreatic cancer has delivered two sets of highly encouraging interim data as well as faster-than-expected patient recruitment leading to an accelerated top-line readout, nine months earlier than planned. The top-line data has now provided further indication of the potential of mitazalimab combined with chemotherapy to confer significant clinical benefit to pancreatic cancer patients over the standard of care. The OPTIMIZE-1 Phase 2 results are a worthy validation of the capabilities of our drug development program. We now need to remain laser focused on our objective to deliver outstanding returns to our stakeholders and to maximize the chances of developing innovative therapies in an ever more challenging Biotech environment. Unfortunately, this initiative will affect our most important asset, our colleagues who have strived professionally and diligently to allow Alligator to deliver on our mission. We could not be more grateful for the efforts and commitment to advance mitazalimab and our other innovative options for those who suffer from hard-to-treat cancers, and we remain committed to supporting those colleagues impacted by this initiative."
Søren Bregenholt, CEO of Alligator Bioscience

BUSINESS UPDATE
Mitazalimab

On October 11, the European Patent Office granted Alligator a new patent covering mitazalimab’s composition of matter until 2038, including a potential supplementary term. The patent expands protection for mitazalimab in Europe and brings the total number of patents in the mitazalimab intellectual property portfolio to 48 granted patents and 25 pending patents covering multiple territories, including Europe, North America, Asia and more.
ATOR-4066

On November 3, Alligator presented a poster entitled "Combination treatment with ATOR-4066, a Neo-X-Prime bispecific antibody targeting CD40 and CEACAM5, and anti-PD-1 reverses T cell exhaustion in vitro" at the 2023 SITC (Free SITC Whitepaper) (Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)) Annual Meeting held in San Diego.
ATOR-1017

On October 5, Alligator announced the publication of a scientific article entitled "ATOR-1017, an Fc-gamma receptor conditional 4-1BB agonist designed for optimal safety and efficacy, activates exhausted T cells in combination with anti-PD-1" in the journal Cancer Immunology, Immunotherapy.
Capital Markets Day

On December 1, Alligator hosted a Capital Markets Day in which members of the Company’s executive management team provided an overview of Alligator’s strategy, its proprietary and partnered assets and its technology platforms. The in-person event was held in Stockholm and live streamed online.
Significant events after the end of the period:
Mitazalimab

On January 29, Alligator announced positive top-line results from the OPTIMIZE-1 Phase 2 trial in pancreatic cancer, demonstrating that mitazalimab in combination with mFOLFIRINOX achieved a 40.4% Overall Response Rate (ORR), a median Duration of Response (DoR) of 12.5 months, and median Overall Survival (mOS) of 14.3 months, which compares favorably to the 11.1 months mOS demonstrated by FOLFIRINOX,[1] and more recently by NALIFIROX in the NAPOLI 3 Phase 3 trial.[2]
Results indicate that mitazalimab in combination with mFOLFIRINOX has the potential to deliver significant clinical benefit for pancreatic cancer patients over standard of care alone.
Alligator has undertaken discussions with the US Food and Drug Administration (FDA) and has been able to establish a clear development and approval pathway for mitazalimab in pancreatic cancer. Based on the emerging data from the OPTIMIZE-1 study, the FDA has provided additional guidance and has endorsed OPTIMIZE-1 as a Phase 3-enabling study. Consequently, mitazalimab can proceed directly to a global Phase 3 registration study, which Alligator is preparing to initiate in early 2025.
ATOR-4066

On January 16, Alligator announced that the United States Patent and Trademark Office (USPTO) had issued a new patent entitled "Novel peptides" which provides protection for ATOR-4066 regarding methods of treating cancer and/or a tumor using a bispecific antibody comprising the complementarity-determining regions (CDRs) of the ATOR-4066 molecule.
Company

Alligator plans to restructure and reduce the workforce with 20-25% to adjust the burn rate and secure its continued ability to invest in the development of mitazalimab and other key value drivers. When fully implemented, the restructuring is expected to reduce annual cost by approximately SEK 20 million.

Outlook into 2024
Alligator continues to advance its Phase 3-enabling activities for the further clinical evaluation of mitazalimab in pancreatic cancer. In addition, Alligator is intensifying its business development efforts to identify the right partner to bring mitazalimab to patients as fast as possible, leveraging its full commercial potential. With the OPTIMIZE-1 top-line data validating CD40 as a target, Alligator sees increased potential in its Neo-X-Prime bispecific antibody ATOR-4066, and will continue efforts to further strengthen its supporting preclinical data package and prepare it for clinical development. Alligator is also expecting the preliminary Phase 1 readout for ALG.APV-527, a bispecific antibody with a tumor-directed 4-1BB agonistic effect being co-developed with Aptevo Therapeutics, in the first half of 2024.

FINANCIAL SUMMARY FOR Q4 2023 and FULL YEAR 2023
The financial summaries for the quarterly periods ending December 31st, 2023 and December 31st, 2022 are presented below.

All amounts in MSEK,
unless specified October – December 2023 October – December 2022
Net Sales 11.7 20.1
Operating profit/loss -70.4 -52.6
Profit/loss for the period -69.8 -53.3
Earnings per share (SEK)
before and after dilution -0.11 -0.24
Cash Flow -7.1 -49.8
Cash & Cash Equivalents 66.1 97.3

The financial summaries for the full year periods ending December 31st, 2023 and December 31st, 2022 are presented below.

All amounts in MSEK,
unless specified January – December 2023 January – December 2022
Net Sales 58.1 35.7
Operating profit/loss -249.0 -192.8
Profit/loss for the period -248.6 -193.4
Earnings per share (SEK)
before and after dilution -0.55 -0.88
Cash Flow -30.2 -180.9
Cash & Cash Equivalents 66.1 97.3
The full report is attached as a PDF, and is also available on the company’s website.
Alligator will host a conference call on Friday, February 9, 2024, at 2 p.m. CET/ 8 a.m. EST for investors, analysts and media, where CEO Søren Bregenholt, CFO Marie Svensson, and CMO Dr. Sumeet Ambarkhane will present and comment on the Year-end report 2023, which will be followed by a Q&A session. The call will be held in English and can be accessed through Alligator’s channel on YouTube.

On February 7, 2024 TJ Biopharma (the "Company") reported that in order to give full play to the advantages of the Company’s R&D system and biopharmaceutical production and enhance the market competitiveness of the Company’s overall innovative drug pipeline, I-Mab Biotech (Hangzhou) Co., Ltd. (the "Company") reported that it has reached an agreement with Nasdaq-listed I-Mab to integrate and reorganize all of I-Mab’s Chinese business, team and pipeline with the Company’s existing pipeline and assets (Press release, TJ Bio, FEB 7, 2024, View Source [SID1234653999]). At the same time, the Company also announced the completion of a C1 round of financing of more than RMB 500 million. This round of financing was jointly invested by Tailong Investment, Zhejiang Province’s "4+1" Biopharmaceutical and High-end Equipment Industry Fund, I-Mab, Hangzhou Qiantang Chengfa Technology Service Co., Ltd., Bruggemoon Limited, and Ningbo Kaitou Hanrun Capital. Haoyue Capital served as the exclusive financial advisor for this transaction.

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After the reorganization is completed, the company will achieve a leapfrog improvement in the R&D system, talent team and commercial production of innovative biological drugs. The integrated innovative drug pipeline includes 10 clinical stage projects (including two products including Etan long-acting growth hormone, which will soon submit applications for listing in China), and 7 innovative drug projects in the preclinical or clinical application stage. The company’s first phase biological drug production base in Qiantang New District, Hangzhou has been put into operation, providing clinical research and recent commercial drug supply. Its 70-acre second phase commercial production base has also completed completion acceptance, which will greatly enhance the company’s ability to provide clinical and commercial drug supply for internal pipelines and domestic and foreign strategic partners.

Dr. Jingwu Zang, founder and chairman of the company, said : "I-Mab has grown rapidly from a start-up to a Nasdaq-listed company, and has continued to evolve and develop amidst the dramatic changes and challenges in the market environment over the past few years. With this strategic reorganization, we will set sail again with China as our foundation to reshape the company’s future and strategic development space. We will leverage our core R&D competitiveness accumulated over the years and our advantages in global project transactions to accelerate the internationalization of early-stage innovative drug projects and realize the phased value of the projects. At the same time, the company will focus on Phase III innovative drug projects to achieve local product commercialization cooperation and sustainable revenue. We will stay true to our original aspiration and aspire to build a leading company in the field of tumor immunotherapy and autoimmune disease treatment in China and even the world, bringing hope and cure to patients."

Mr. Jin Yufeng, Chairman of Heda Financial, the Executive Representative of Zhejiang Province’s "4+1" Biopharmaceutical and High-end Device Industry Fund, said : "The Tianjing team has first-class innovative drug research and development, production and global commercial transaction capabilities in the field of immunology, and has a technology platform of tumor-targeted bispecific antibodies with independent and complete intellectual property rights and first-of-its-kind antibody-small molecule inhibitor fusion drugs. It has laid out mature and differentiated clinical pipelines in multiple tumor and autoimmune treatment fields. The total scale of Zhejiang Province’s "4+1" Biopharmaceutical and High-end Device Industry Fund is 5 billion. After its establishment in October 2023, during the cold winter of pharmaceutical investment, it accelerated investment and support for the pharmaceutical industry against the trend. This participation in the reorganization of Tianjing Hangzhou is an important investment layout of the fund in 2023. We are very optimistic about the capabilities of the Tianjing team and hope that Tianjing Hangzhou will become the leader of innovative drug research and development companies in Hangzhou, help the construction of Qiantang China Pharmaceutical Port, and contribute to the biopharmaceutical industry in Zhejiang Province and even China."

Mr. Ding Yameng, Founding Managing Partner and COO of Haoyue Capital, said : "Haoyue Capital is honored to serve as the exclusive financial advisor for Hangzhou Tianjing’s C1 round of financing and assist the company in completing this transaction. Although the capital market is in a periodic adjustment, truly outstanding companies and entrepreneurs will actively seek change and bravely meet challenges. Congratulations to Hangzhou Tianjing for successfully completing its C1 round of financing. We are firmly optimistic that Hangzhou Tianjing will grow into a leading Chinese biopharmaceutical company integrating R&D, production and product cooperative sales in the future."