On August 14, 2024 Novocure (NASDAQ: NVCR) reported its participation in the upcoming International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC) from September 7 – 10, 2024 in San Diego, California (Press release, NovoCure, AUG 14, 2024, View Source [SID1234645937]). Novocure will take part in presentations and symposia throughout the event and will exhibit several posters exploring the use of Tumor Treating Fields (TTFields) therapy in the treatment of lung cancer, including a new post-hoc analysis of data from the LUNAR trial in metastatic non-small cell lung cancer (NSCLC).

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"We are eager to share these exciting new analyses with the lung cancer community," said Nicolas Leupin, MD, Novocure’s Chief Medical Officer. "TTFields therapy offers significant potential for the treatment of this prevalent disease. With multiple regulatory reviews underway, there is no better time to examine the promise of TTFields use in the treatment of NSCLC."

The new post-hoc analysis evaluated survival data from the phase 3 LUNAR clinical trial, as well as a data from a simulation study, to assess the effect of body mass index (BMI) on overall survival (OS) and the feasibility of delivering TTFields at a therapeutic intensity to patients of varying BMIs. Investigators did not identify a difference in OS benefit between patients with a BMI <25 kg/m2 compared a BMI >25 kg/m2. Additionally, data from the simulation-based study suggests TTFields can be delivered to the lungs in therapeutic dose and a corresponding clinical benefit observed in patients across a range of BMIs.

The LUNAR trial was designed to evaluate the use of TTFields therapy together with standard systemic therapies for the treatment of metastatic non-small cell lung cancer, following progression on or after platinum-based therapy. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful extension in OS for patients treated with TTFields and standard systemic therapies, as well as a pronounced extension in OS for patients randomized to receive physician’s choice immune checkpoint inhibitor together with TTFields. Novocure has submitted these data to regulatory agencies for approval and anticipates treating patients in late 2024.

Novocure’s presence at the 2024 WCLC will include:

Sunset Seminar: Women in Thoracic Oncology, hosted by Women Leaders in Oncology (WLO), sponsored by Novocure, on September 8, 2024, at 6:00 p.m. UTC-7
Impact of BMI on TTFields in Patients with mNSCLC: Post-hoc Analysis from the Phase 3 LUNAR Study and Simulation Model Data. Poster P1.098B.04 displayed in the Exhibit Hall on September 8, 2024, at 12:00 p.m. UTC-7
Treatment of Non-Small Cell Lung Carcinoma (NSCLC) Cells With Tumor Treating Fields (TTFields) and DNA-Dependent Protein Kinase (PK) Inhibitors. E-Poster EP.03F.04
Tumor Treating Fields (TTFields) Induce Pro-Inflammatory Phenotype Skewing of Macrophages. E-Poster EP.03G.03

ABOUT TUMOR TREATING FIELDS THERAPY

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

ABOUT LUNAR

LUNAR tested the safety and effectiveness of TTFields therapy when used together with either an immune checkpoint inhibitor (ICI) or docetaxel for the treatment of patients diagnosed with metastatic NSCLC following progression on or after the use of platinum-based therapy. Patients randomized to receive TTFields therapy together with standard therapies (n=137) demonstrated median overall survival (OS) of 13.2 months compared to 9.9 months in patients treated with standard therapies alone (n=139). Patients randomized to receive TTFields therapy and physician’s choice ICI (n=66) demonstrated a median OS of 18.5 months versus a median OS of 10.8 months in patients treated with an ICI alone (n=68; HR=0.63; P=0.03). Patients randomized to receive TTFields therapy and docetaxel (n=71) had a positive survival trend with a median OS of 11.1 months vs 8.7 months in patients treated with docetaxel alone (n=71). TTFields therapy was well-tolerated with no added systemic toxicities and few grade 3 (no grade 4 or 5) device-related adverse events.

On August 14, 2024 Aileron Therapeutics, Inc. ("Aileron" or the "Company") (NASDAQ: ALRN), a biopharmaceutical company advancing a pipeline of potential first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, reported financial results for the second quarter ended June 30, 2024, and provided a business update (Press release, Aileron Therapeutics, AUG 14, 2024, View Source [SID1234645885]).

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"Throughout the first half of the year, we focused on strengthening our balance sheet and advancing the development of inhaled LTI-03 in IPF," said Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron. "We are extremely pleased with the positive data from Cohort 1 of the ongoing Phase 1b clinical trial announced in May, particularly the achievement of statistical significance in three out of eight biomarkers which is a testament to the potential of LTI-03 to inhibit fibrosis and improve lung function. Additionally, in May, we raised approximately $18.2 million in net proceeds in an underwritten registered direct offering, which provides us with the resources to further validate LTI-03 in the ongoing Phase 1b trial. We look forward to reporting topline results from the high-dose cohort in the third quarter of this year."

Second Quarter 2024 Highlights and Recent Updates

Corporate Updates

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In May 2024, the Company completed an underwritten registered direct offering of 4,273,505 shares of its common stock and accompanying warrants to purchase an aggregate of 4,273,505 shares of its common stock. Net proceeds from the offering were approximately $18.2 million, after deducting underwriting discounts and commissions and other offering expenses. The Company has the potential to receive approximately $20.0 million in additional proceeds from the exercise of the warrants issued in the offering.

Pipeline

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Announced positive Cohort 1 data from the ongoing Phase 1b clinical trial evaluating the safety and tolerability of inhaled LTI-03 in patients diagnosed with IPF.

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Following inhaled administration of low dose LTI-03 (2.5 mg BID, or twice daily) in twelve patients, a positive trend was observed in seven out of eight biomarkers. The findings included:

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Evidence of LTI-03 reducing expression of multiple profibrotic proteins produced in both basal-like cells and fibroblasts that contribute to the progression of IPF, with statistically significant decreases in three biomarkers, reinforcing the potential of LTI-03 to inhibit fibrosis, inflammation and associated changes in the lungs.

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LTI-03 stimulated production of solRAGE, a factor indicative of type I epithelial cell health, a critically important aspect of IPF that has gone largely unaddressed.

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LTI-03 was generally well-tolerated with no serious adverse events ("SAEs") reported.

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The Phase 1b trial is ongoing, with topline results from the high-dose Cohort 2 expected in the third quarter of 2024.

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On May 1, 2024, the Company hosted a pulmonary care expert call to discuss the Cohort 1 Phase 1b results of LTI-03, featuring pulmonary care expert Andreas Günther, M.D., Head of the Center for Interstitial and Rare Lung Diseases at the Justus Liebig University in Giessen, Germany. A replay of the event can be accessed at View Source
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LTI-01 is in development for loculated pleural effusion ("LPE"), a serious consequence of pneumonia with significant unmet medical need.

Second Quarter 2024 Financial Results
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Cash Position: Cash and cash equivalents as of June 30, 2024, were $21.9 million, compared to $12.0 million as of March 31, 2024. After including the net proceeds raised from the May 2024 offering and based on its current operating plan, the Company expects its existing cash and cash equivalents to be sufficient to fund the completion of the Phase 1b clinical trial and its operations into the second half of 2025.

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Research and Development ("R&D") Expenses: R&D expenses for the quarter ended June 30, 2024, were $3.7 million, compared to $0.2 million for the quarter ended June 30, 2023. The increase of $3.5 million was primarily a result of the clinical programs acquired as part of the Company’s acquisition of Lung Therapeutics, Inc. in October 2023 (the "Lung Acquisition"). During the quarter ended June 30, 2024, Aileron incurred expenses of $1.1 million on clinical trials, $2.0 million on manufacturing, and $0.1 million on regulatory and development consulting as well as $0.5 million on employee and related expenses associated with clinical programs acquired in the Lung Acquisition.

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General and Administrative ("G&A") Expenses: G&A expenses for the quarter ended June 30, 2024, were $5.3 million, compared to $1.9 million for the quarter ended June 30, 2023. The increase of $3.4 million was primarily due to increased professional fees of $1.0 million and increased employee and related expenses of $1.8 million as a result of increased business activity and headcount associated with the Lung Acquisition, and increased facilities and other expenses of $0.5 million during the quarter ended June 30, 2024 as compared to the quarter ended June 30, 2023.

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Net Loss: Net loss for the quarter ended June 30, 2024, was $8.9 million, compared to $1.8 million for the quarter ended June 30, 2023. The basic and diluted net loss per share for the quarter ended June 30, 2024 was $0.45 compared to $0.39 for the quarter ended June 30, 2023.

On August 14, 2024 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies ("ETBs"), to create novel therapies with potent differentiated mechanisms of action, reported financial results and business updates for the second quarter of 2024 (Press release, Molecular Templates, AUG 14, 2024, View Source [SID1234645922]).

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"ETBs can eliminate immune cells that monoclonal antibodies cannot. Eliminating MDSCs with MT-6402 and Tregs with MT-8421 is a novel approach to immuno-oncology that is demonstrating durable responses in patients who have progressed or were refractory to checkpoint therapy. The elimination of immunosuppressive cells in patients with tumor microenvironments that promote immune evasion may drive long-lasting responses in patients who have exhausted other treatment options," said Eric Poma, PhD., Chief Executive and Chief Scientific Officer of MTEM. "Similarly, we believe MT-0169 can eliminate CD38+ immune cells that antibodies cannot, allowing for potentially greater potency in both hematologic malignancies and autoimmune diseases."

Recent Company Highlights

MT-6402: Continued monotherapy activity in patients who progressed or were refractory to checkpoint therapy
Nine patients (seven evaluable) with low PD-L1+ HNSCC were dosed in the MT-6402 phase I dose escalation study. Two patients remain in partial responses at cycle 23 and cycle 14 (one cycle is 4 weeks). Both patients had progressed after multiple lines of checkpoint therapy. In the high PD-L1+ dose expansion cohort, four NSCLC patients (three evaluable) have been enrolled. and one patient is in a partial response at cycle 11; the patient had progressed on chemotherapy, targeted therapy, and checkpoint therapy. All responding patients were heavily pretreated (3 or more lines of previous therapy including checkpoint) and have been on MT-6402 longer than any other previous therapy. MTEM continues to enroll HNSCC patients with low PD-L1 expression (1-49%) and patients with solid tumors with high PD-L1 expression (≥50%).
MT-8421: Enrollment in Phase 1 dose escalation ongoing with continued observation of unique pharmacodynamic profile (peripheral and TME Treg depletion) and signs of monotherapy activity
Five melanoma patients were evaluable in the first two dose cohorts (32 and 48 mcg/kg); no drug related adverse events > grade 2 were observed. One patient remains on study in cycle 11 with a 27% decrease in tumor volume and reduction in circulating tumor DNA from 3.13 to 0 MTM/mL. This patient had a >90% reduction in peripheral Tregs and a ~66% reduction of Tregs in the TME. The patient had progressed on pembrolizumab in the adjuvant setting and then progressed on ipilimumab (4 doses at 3mg/kg) and nivolumab in the metastatic setting.
MT-0169: Potential in severe autoimmune diseases being explored based on clinical demonstration of complete elimination of CD38+ immune cells at dose levels with no drug-related adverse events > grade 2.
The potent and unique mechanism of action of MT-0169 is not subject to resistance mechanisms associated with monoclonal antibodies like trogocytosis and can eliminate high-expressing CD38 immune cells like plasma cells as well as low-expressing CD38+ cells like HLA-DR CD38+ T-cells. This mechanism of action does not require conditioning therapy. MTEM will continue to develop MT-0169 in hematologic malignancies and is evaluating the potential of MT-0169 in severe immune-mediated diseases.
Upcoming Milestones for 2H 2024

Additional updates from the MT-6402 low PD-L1+ HNSCC and high PD-L1+ solid tumor expansions studies in 3Q24.
Additional updates from the MT-8421 dose escalation study in 3Q24.
MT-0169 Phase 1 study initiation in CD38+ hematological malignancies and continued evaluation in autoimmune disease.
Upcoming Conferences

MTEM will participate at the H.C. Wainwright 26th Annual Global Investment Conference taking place at the New York Lotte Palace Hotel, September 9 – 11, 2024. An on-demand presentation will be accessible virtually starting 7:00am ET September 9, 2024 via MTEM corporate website. One-on-one meetings may be scheduled by directly contacting MTEM.

Second Quarter 2024 Financial Results

The net loss attributable to common shareholders for the second quarter of 2024 was $8.1 million, or $1.23 per basic and diluted share. This compares with a net loss attributable to common shareholders of $10.9 million, or $2.89 per basic and diluted share, for the same period in 2023.

Revenues for the second quarter of 2024 were $0.6 million, compared to $6.9 million for the same period in 2023.

Total research and development expenses for the second quarter of 2024 were $5.4 million, compared with $13.4 million for the same period in 2023. Total general and administrative expenses for the second quarter of 2024 were $3.5 million, compared with $5.2 million for the same period in 2023.

As of June 30, 2024, MTEM’s cash and cash equivalents totaled $9.7 million. The Company expects that its cash and cash equivalents for the quarter ended June 30, 2024 will support its ongoing operations into the fourth quarter of 2024.

Molecular Templates, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)

Three Months Ended
June 30, Six Months Ended
June 30,
2024
2023
2024
2023
Research and development revenue $ 189 $ 6,627 $ 11,113 $ 40,254
Grant revenue 383 238 545 3,240
Total revenue 572 6,865 11,658 43,494
Operating expenses:
Research and development 5,402 13,413 12,807 32,455
General and administrative 3,466 5,195 7,197 10,997
Total operating expenses 8,868 18,608 20,004 43,452
Income/(loss) from operations (8,296 ) (11,743 ) (8,346 ) 42
Interest and other income, net 130 365 239 820
Interest and other expense, net (38 ) (1,189 ) (69 ) (2,584 )
Gain on extinguishment of debt — 1,795 — 1,795
Change in valuation of contingent value right 107 303 651 303
Loss on disposal of property and equipment — (399 ) — (399 )
Net loss attributable to common stockholders $ (8,097 ) $ (10,868 ) $ (7,525 ) $ (23 )
Net loss per share attributable to common stockholders:
Basic and diluted $ (1.23 ) $ (2.89 ) $ (1.26 ) $ (0.01 )
Weighted average number of shares used in net loss per share calculations:
Basic and diluted 6,557,295 3,756,711 5,965,781 3,756,711

Molecular Templates, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)

June 30,
2024
(unaudited) December 31,
2023
ASSETS
Current assets:
Cash and cash equivalents $ 9,657 $ 11,523
Prepaid expenses 787 2,195
Grants revenue receivable 795 250
Other current assets 777 2,804
Total current assets 12,016 16,772
Operating lease right-of-use assets 8,124 9,161
Property and equipment, net 5,238 7,393
Other assets 1,319 2,057
Total assets $ 26,697 $ 35,383
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 2,773 $ 1,523
Accrued liabilities 2,270 4,279
Deferred revenue, current — 9,031
Other current liabilities 2,637 2,488
Total current liabilities 7,680 17,321
Operating lease liabilities, long term portion 8,390 9,742
Contingent value right liability 2,051 2,702
Other liabilities 1,465 1,406
Total liabilities 19,586 31,171
Commitments and contingencies
Stockholders’ equity
Preferred stock, $0.001 par value per share:
Authorized: 2,000,000 shares as of June 30, 2024 and December 31, 2023; Issued and outstanding: 250 shares as of June 30, 2024 and December 31, 2023 — —
Common stock, $0.001 par value per share:
Authorized: 150,000,000 shares as of June 30, 2024 and December 31, 2023; Issued and outstanding: 6,583,880 and 5,374,268 shares as of June 30, 2024 and December 31, 2023, respectively 7 5
Additional paid-in capital 467,521 457,099
Accumulated deficit (460,417 ) (452,892 )
Total stockholders’ equity 7,111 4,212
Total liabilities and stockholders’ equity $ 26,697 $ 35,383

Second tranche of July 2023 Private Placement

We closed the second tranche of the July 2023 Private Placement on April 2, 2024 with gross proceeds of approximately $9.5M. The Company intends to use the net proceeds from the second tranche to fund its ongoing clinical studies, working capital and for general corporate purposes.

On August 14, 2024 MediGene reported its half-yearly 2024 results (Presentation, MediGene, AUG 14, 2024, View Source [SID1234645981]).

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On August 14, 2024 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported the pricing of an underwritten offering of 2,750,498 shares of its common stock at a price of $36.50 per share, representing a premium of approximately 10% to Anaptys’ closing price on Aug. 13, 2024 (Press release, AnaptysBio, AUG 14, 2024, View Source [SID1234645886]). The gross proceeds from this offering are expected to be approximately $100 million, before deducting underwriting discounts, commissions and other offering expenses payable by Anaptys. All of the shares of common stock are being offered by Anaptys. The offering is expected to close on or about Aug. 15, 2024, subject to the satisfaction of customary closing conditions.

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The offering was led by current investor, EcoR1 Capital, and included participation from both new and existing investors, including Cormorant Asset Management, Farallon Capital Management, First Light Asset Management, Woodline Partners LP, multiple large investment management firms and Sanofi.

"We are excited to announce this focused equity offering, with proceeds intended to be used primarily to accelerate and support the enablement of Phase 3 trials for ANB032, our BTLA agonist, in Phase 2b development in atopic dermatitis, as well as rosnilimab, our PD-1 agonist, in Phase 2b development in rheumatoid arthritis and Phase 2 development in ulcerative colitis," said Daniel Faga, president and chief executive officer of Anaptys. "We are pleased with the quality of our existing and new long-term investors, who share our enthusiasm for the potential of checkpoint agonists to bring the immune system back to homeostasis and durably modify autoimmune and inflammatory diseases."

Anaptys intends to use the net proceeds of this offering primarily for general corporate purposes, which may include funding Phase 3 enabling activities for ANB032 and rosnilimab, working capital and general corporate purposes. Sanofi did not receive rights to any of Anaptys’ programs as a part of their equity investment.

TD Cowen, Leerink Partners, Piper Sandler and Guggenheim Securities are acting as joint book-running managers for the offering.

The shares are being offered by Anaptys pursuant to a registration statement previously filed and declared effective by the U.S. Securities and Exchange Commission ("SEC"). A prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and accompanying prospectus may also be obtained, when available, from: TD Securities (USA) LLC, 1 Vanderbilt Ave., New York, NY 10017, by telephone at (855) 495-9846, or by email at [email protected] or from Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

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