On August 16, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported its financial results for the second quarter 2024 (Press release, AIM ImmunoTech, AUG 16, 2024, View Source [SID1234645959]). As previously announced, the Company will host a conference call and webcast today, Friday, August 16, 2024, at 8:30 AM ET (details below).

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"We continue to see great potential in Ampligen as we progress across our clinical development programs and look forward to results from our ongoing studies in the near future. Our entire team remains dedicated to patients and stockholders and will continue to drive momentum across our operational, clinical and regulatory initiatives throughout the remainder of 2024. We strongly believe in the potential of Ampligen to have a meaningful therapeutic benefit across multiple indications as well as the opportunity to unlock significant shareholder value," commented AIM Chief Executive Officer, Thomas K. Equels.

Recent Highlights

Announced new positive data on Ampligen’s anti-tumor potential when used as part of a combination therapy for the treatment of melanoma
A manuscript of the results titled, "Therapeutic Anti-Tumor Efficacy of DC-Based Vaccines Targeting TME-Associated Antigens is Improved When Combined with a Chemokine-Modulating Regimen and/or Anti-PD-L1" was published in the peer-reviewed journal Vaccines.
Released several CEO Corner segments highlighting Company news and programs
Summary of Financial Highlights for Second Quarter 2024

As of June 30, 2024, AIM reported cash, cash equivalents and marketable securities of $10.1 million.
Research and development expenses for the three months ended June 30, 2024, were $1.1 million, compared to $3.0 million for the same period in 2023. Expenses for the six months ended June 30, 2024, were $3.1 million, compared to $5.0 million for the same period in 2023.
General and administrative expenses were $2.6 million for the three months ended June 30, 2024, compared to $2.6 million for the same period 2023. Expenses were $6.4 million for the six months ended June 30, 2024, compared to $4.8 million for the same period in 2023.
The net loss from operations for the three months ended June 30, 2024, was $1.8 million, or $0.03 per share, compared to $4.9 million, or $0.10 per share, for the same period in 2023. Net loss for the six months ended June 30, 2024, was $7.7 million, or $0.15 per share, compared to $8.6 million, or $0.18 per share, for the same period in 2023.
Please refer to the full 10-Q for complete details.

Conference Call and Webcast Details

As previously announced, the Company will host a conference call and webcast to discuss the Company’s Q2 2024 operational and financial results today, August 16, 2024 at 8:30 AM ET.

The call will be hosted by members of AIM’s leadership team, Thomas K. Equels, Chief Executive Officer and Christopher McAleer, PhD, Scientific Officer. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The webcast will be accessible on the Events page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.

On August 16, 2024 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the "Company"), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte ("TIL") therapies for patients with cancer, reported that on August 15, 2024 (the "Date of Grant"), the Company approved the grant of inducement stock options and restricted stock units covering an aggregate of 289,710 shares of Iovance’s common stock to twenty-four new, non-executive employees (Press release, Iovance Biotherapeutics, AUG 16, 2024, View Source [SID1234645960]).

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The awards were granted under Iovance’s 2021 Inducement Plan, which was adopted on September 22, 2021 and amended on January 12, 2022, March 13, 2023, and February 26, 2024 and provides for the granting of equity awards to new employees of Iovance by the Company’s compensation committee in accordance with Nasdaq Listing Rule 5635(c)(4). Each of the stock options granted as referenced in this press release has an exercise price of $10.67, the closing price of Iovance’s common stock on the Date of Grant. Each stock option and restricted stock unit vests over a three-year period, with one-third of the shares vesting on the first anniversary of the employee’s start date (the "First Vesting Date"), and the remaining shares vesting in eight quarterly installments over the next two years, commencing with the first quarter following the First Vesting Date, subject to continued employment with the Company through the applicable vesting dates.

On August 16, 2024 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a Phase 3 clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported the pricing of a public offering of an aggregate of 2,466,368 shares of its common stock (or common stock equivalents in lieu thereof), Series A warrants to purchase up to 2,466,368 shares of common stock and Series B warrants to purchase up to 2,466,368 shares of common stock, at a combined public offering price of $2.23 per share (or per common stock equivalent in lieu thereof) and accompanying warrants (Press release, Moleculin, AUG 16, 2024, View Source [SID1234645961]).

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The Series A warrants have an exercise price of $2.23, are exercisable immediately upon Shareholder Approval (as defined below) and will expire upon the earlier of (i) the 2 year anniversary of the date of Stockholder Approval (as defined below) and (ii) the 60th day following the date the Company releases interim data for the first subject group from the MIRACLE trial whereby the complete remission rate for either doses of the Company’s study drug is greater than placebo. The Series B warrants have an exercise price of $2.23, are exercisable immediately upon Shareholder Approval (as defined below) and will expire upon the earlier of (i) the 5 year anniversary of the date of Stockholder Approval (as defined below) and (ii) the 6 month anniversary following the date the Company releases final topline data from the MIRACLE trial and documented a statistically significant improvement in the primary efficacy endpoint. Pursuant to Nasdaq Listing Rule 5635(d), the exercise of the Series A warrants and Series B warrants is subject to shareholder approval (the "Shareholder Approval"). The closing of the offering is expected to occur on or about August 19, 2024, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $5.5 million and up to an additional approximately $11.0 million in gross proceeds if the warrants are fully exercised for cash. The Company intends to use the net proceeds from this offering to advance Annamycin and its other two drug portfolios through clinical development, advance the remainder of the Company’s existing portfolio through preclinical studies and into INDs or their equivalent, sponsor research at MD Anderson and HPI, and for working capital.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-280951), which was declared effective by the Securities and Exchange Commission (the "SEC") on August 15, 2024. The offering is being made only by means of a prospectus forming part of the effective registration statement relating to the offering. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The Company also has agreed to amend certain existing warrants to purchase up to an aggregate of 895,834 shares of common stock that were previously issued in December 2023 and have an exercise price of $9.60 per share such that the amended warrants will have a reduced exercise price of $2.23 per share effective upon the closing of the offering, will be exercisable beginning on the effective date of Stockholder Approval of the issuance of the shares upon exercise of the warrants and will expire five years from the date of Stockholder Approval.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On August 15, 2024 Exscientia reported recent advancements in the Company’s pipeline, collaborations and operations, as well as financial results for the second quarter and first half 2024 (Press release, Exscientia, AUG 15, 2024, View Source [SID1234645944]).

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"Last week, we announced that Exscientia entered into a definitive agreement to combine with Recursion Pharmaceuticals," said David Hallett, Ph.D., interim Chief Executive Officer and Chief Scientific Officer of Exscientia. "When we bring together our platforms at closing, our world class scientists and Exscientia’s best-in-class focused precision oncology internal pipeline with Recursion’s first-in-class focused pipeline, we believe we will be able to discover better drugs for patients faster and at a lower cost."

"In the first half of 2024, we believe we have made important progress across our AI-powered pipeline and progress towards autonomous drug design as well as deepening our technology and pharma partnerships," continued David Hallett, Ph.D. "We made the strategic decision to fully invest in our CDK7 inhibitor GTAEXS617 (‘617) by acquiring full rights to the programme, which we believe is highly differentiated and demonstrates the power of our design capabilities. We look forward to sharing topline data later this year."

Key Business Updates

Transaction with Recursion
●Earlier this month, Exscientia entered into a definitive agreement to combine with Recursion Pharmaceuticals in a transaction that will create a company positioned to leverage the latest life sciences and technology advances to deliver better, novel treatments to patients, faster and at a lower cost relative to traditional drug discovery and development methods
oThis combination will bring together Recursion’s scaled biology exploration and translational capabilities with Exscientia’s precision chemistry design and small molecule automated synthesis capabilities to create, at closing, a leading technology-first, end-to-end drug discovery platform

Internal Precision Oncology Pipeline
●The Company continues to enrol patients with advanced solid tumours in its Phase 1/2 ELUCIDATE trial evaluating ‘617, a potential best-in-class CDK7 inhibitor
○In July, the Company announced that it reached an agreement to acquire the full rights to ‘617 from its partner GT Apeiron – with GT Apeiron retaining an interest via an increased ownership stake in Exscientia
○The Company remains on track to announce topline pharmacokinetic, pharmacodynamic and safety data from the dose escalation phase of ELUCIDATE in the second half of this year
○Exscientia expects to transition to the dose expansion phase of ELUCIDATE in the second half of this year or early next year, starting with the evaluation of ‘617 in HR+/HER2- breast cancer in combination with a selective estrogen receptor degrader (SERD)
●EXS74539 (‘539), Exscientia’s highly differentiated, brain penetrant LSD1 inhibitor, continues to advance towards the clinic, with an IND expected to be submitted later this year. The Company expects to initiate a Phase 1/2 clinical trial in early 2025
●Exscientia remains on track to submit a CTA for EXS73565 (‘565), the Company’s potential best-in-class MALT1 inhibitor, in the second half of 2024. The Company expects to initiate a Phase 1/2 clinical trial of ‘565 in B-cell malignancies, including chronic lymphocytic leukaemia (CLL), in early 2025

Collaborations & Partnerships
●The Sanofi partnership, with a primary focus on immunology and inflammation, continues to advance with multiple potential near-term milestones
●Exscientia continues to make progress in its collaboration with Merck KGaA, Darmstadt, Germany with multiple programmes already in early discovery
●In July 2024 the Company announced a collaboration with READDI, a non-profit biotechnology initiative funded by the National Institute of Allergy and Infectious Disease (NIAID), to evaluate and improve a range of AI-designed antiviral compounds for pandemic preparedness
○Exscientia will use its generative AI capabilities to design novel compounds to fight coronaviruses with READDI providing antiviral expertise as well as funding testing and analyses

Drug Discovery Platform
●Exscientia announced the expansion of its work with Amazon Web Services (AWS) to use the cloud provider’s artificial intelligence and machine learning services to power its platform for end-to-end drug discovery and automation
oExscientia’s state-of-the-art platform, built using AWS technologies, integrates generative AI drug design and robotic lab automation to further accelerate drug development at a lower cost
oThe Company’s closed loop "Design-Make-Test-Learn" facility is now fully online and the first compounds have rolled off the production line. These were designed using Exscientia’s proprietary synthesis aware GenAI and manufactured and tested using the Company’s in-house state-of-the-art automation facility

Leadership Updates
●Marie-Louise Fjallskog, M.D., Ph.D., was appointed interim Chief Medical Officer, bringing extensive oncology drug development expertise to execute robust clinical strategy on Exscientia’s internal oncology pipeline
●Nicola Richmond, Ph.D., will be joining Exscientia in September as Chief Scientist, AI. Holding a Ph.D. in mathematics, she brings over 20 years’ experience operating at the intersection of drug discovery and technology. Dr. Richmond will be leading efforts in developing AI solutions for the Company’s drug discovery efforts

Second Quarter and First Half 2024 Financial Results
For the convenience of the reader, the Company has translated pound sterling amounts to U.S. dollars at the rate of £1.000 to $1.2640, which was the noon buying rate of the Federal Reserve Bank of New York on June 28, 2024.

Revenue: Revenue for the three and six months ended June 30, 2024 was $5.6 million and $12.3 million, compared to $3.8 million and $11.1 million for the three and six months ended June 30 2023. The increase in revenue year over year was primarily due to an increase in the number of active projects in the first half of 2024 relative to the prior period.

Research and development expenses (R&D): R&D expenses for the three and six months ended June 30, 2024 were $31.7 million and $61.5 million respectively, as compared to $41.7 million and $83.9 million for the same period ended June 30, 2023. The decrease in research and development expenses was primarily due to cost reductions relating to pipeline prioritisation activities implemented during the second half of 2023 and cost savings from operational efficiencies.

General and administrative expenses (G&A): G&A expenses for the three and six months ended June 30, 2024 were $21.2 million and $25.6 million, respectively, or 34% and 24% of total operating expenses. For the three months ended June 30, 2024, G&A expenses increased by $6.5 million compared to the prior year, primarily driven by current quarter severance and termination-related costs totalling $7.5m relating to the cost saving and efficiency measures announced in May 2024. For the six months ended June 30, 2024, G&A expenses decreased by $2.9 million compared to the prior year due to credits totalling $7.5 million relating to amounts recognised in February 2024 on the forfeiture of share options held by the Company’s prior CEO upon his exit from the Company.

Cash inflows: For the second quarter 2024, Exscientia received $1.4 million in cash inflows from its collaborations as compared to $0.7 million during the second quarter 2023.

Net operating cash flow and cash balance: For the three and six months ended June 30, 2024, net operating cash outflows were $45.8 million and $84.8 million respectively, in comparison to $52.2 million and $107.0 million for the three and six months ended June 30, 2023. Cash, cash equivalents and short-term bank deposits as of June 30, 2024 were $370.1 million, as compared to $458.9 million as of December 31, 2023 using the June 28, 2024 constant currency rate.

On August 15, 2024 Pathos AI, Inc. (www.pathos.com), a biotechnology company focused on revolutionizing precision medicine in cancer by harnessing the power of machine learning to transform drug development, reported the world-wide license of PRT811, a potent, selective, and orally bioavailable brain penetrant SAM-competitive PRMT5 inhibitor from Prelude Therapeutics (Press release, Pathos AI, AUG 15, 2024, View Source [SID1234653830]).

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PRT811 (renamed P-500) was developed by Prelude Therapeutics and completed a Phase 1 trial in March 2023. The trial enrolled patients with solid tumors including high-grade glioma and uveal melanoma and has potential application in other indications with high unmet need. Out of 16 patients with high-grade glioma with isocitrate dehydrogenase mutations (IDH+) in the Phase 1 trial, two confirmed complete responses (CR) were observed. At last follow-up, 1 response is ongoing and has lasted 31.0 months while the duration of response for the second CR patient was 7.5 months. Additionally, 1 patient achieved an unconfirmed partial response (PR).

In addition, out of 23 uveal melanoma patients (10 patients with splicing factor 3B subunit 1 (SF3B1) splicing mutations and 13 without an SF3B1 mutation), one confirmed PR (duration of response of 10 months) and a second unconfirmed PR were observed, both in patients SF3B1 mutations.

In the entire safety population (N=86), the most common adverse events of any grade, with an incidence of >20% were nausea (60.5%), vomiting (46.5%) fatigue (36.0%), constipation (29.1%), and thrombocytopenia (24.4%), and were predominantly grade 1-2. The most common adverse events (grade ≥3), occurring >5% were thrombocytopenia (9.3%), anemia (9.3%), and fatigue (5.8%).

"These results from Prelude’s Phase 1 study are promising news for high-grade glioma patients and clinicians, who still have limited treatment options with chemotherapy and radiation that hasn’t changed in decades. With our AI Platform, we aim to increase the already encouraging response rate of P-500 through a novel biomarker-driven strategy, ultimately bringing this medicine to patients as efficiently as possible," said Ryan Fukushima, Pathos CEO.

"Prelude’s discovery engine has delivered a number of first- or best-in-class precision medicines including PRT811, a molecule that has shown early promise in the treatment of high-grade glioma. We are confident that Pathos AI, sharing our passion for precision medicine and commitment to serving cancer patients with high unmet need, is an ideal company to drive the development of this molecule forward for patients." said Sean Brusky, Prelude CBO. "The resources from this transaction will support advancing Prelude’s pipeline."

About P-500
P-500 (previously PRT811) is a selective, brain-penetrant small molecule inhibitor of protein arginine methyltransferase 5 (PRMT5) that has the potential to provide clinical benefit for patients with advanced solid tumors, including high-grade glioma and uveal melanoma.

PRMT5 is an enzyme that adds methyl groups to proteins in cells using a molecule called S-adenosylmethionine (SAM) which regulates protein function and interactions. Several processes that support cancer cell growth and spread depend on PRMT5, making P-500 relevant not only to advanced high-grade glioma and uveal melanoma (in which objective responses to P-500 were observed in the Phase 1 clinical trial) but also to a number of other cancer indications. Preclinical studies have demonstrated PRMT5 inhibition can sensitize cancer cells to other treatments, expanding the application of P-500 to combination therapy in additional indications.