Tonix Pharmaceuticals to Present at the Alliance Global Partners (A.G.P) Healthcare Company Showcase

On May 15, 2024 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, reported that Seth Lederman, M.D., Chief Executive Officer, will participate virtually in a fireside chat at A.G.P.’s Healthcare Company Showcase on Tuesday, May 21, 2024, at 9:00 a.m. ET (Press release, TONIX Pharmaceuticals, MAY 15, 2024, View Source [SID1234643363]).

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A live webcast of the presentation can be found here. A replay of the presentation will also be available under the IR Events tab of the Tonix website at www.tonixpharma.com following the event.

Phio Pharmaceuticals Announces Completion of Dosing in First Patient Cohort in PH-762 Phase 1b Dose-Escalation Study

On May 15, 2024 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, reported progress on its Phase 1b clinical study for their lead compound PH-762 (Press release, Phio Pharmaceuticals, MAY 15, 2024, https://phiopharma.com/phio-pharmaceuticals-announces-completion-of-dosing-in-first-patient-cohort-in-ph-762-phase-1b-dose-escalation-study/ [SID1234643362]). Dosing of the first cohort of patients was completed and screening for the next dose cohort is on-going.

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Phio’s Phase 1b study (NCT 06014086) is a multi-center, dose-escalating clinical trial designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. This study will assess the tumor response, and determine the recommended dose for further study of PH-762.

"This is exciting news for Phio and our lead compound PH-762 with the dosing of the 1st cohort completed, we look forward to advancing the study to bring an innovative treatment option to patients with skin carcinomas," said Robert Bitterman, CEO of Phio Pharmaceuticals.

Adaptimmune Reports Q1 2024 Financial and Business Updates

On May 15, 2024) – Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, reported financial results and business updates for the first quarter ended March 31, 2024 (Press release, Adaptimmune, MAY 15, 2024, View Source [SID1234643361]). The Company will host a live webcast at 8:00 a.m. EDT (1:00 p.m. BST) today.

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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "Support from the sarcoma community continues to highlight the high unmet medical need for new therapies for synovial sarcoma and we are making great progress preparing for the commercial launch of afami-cel on approval. Behind afami-cel, we plan to launch lete-cel for synovial sarcoma and MRCLS in 2026 with projected peak US sales of $400 million for our sarcoma franchise."

Sarcoma Franchise with afami-cel and lete-cel

U.S. FDA accepted the BLA for afami-cel for the treatment of advanced synovial sarcoma with priority review and a PDUFA date of August 4th, 2024
The BLA mid-cycle review meeting was held with FDA in April
FDA GCP Bioresearch Monitoring Program (BIMO) inspections have been conducted at Adaptimmune and at selected clinical sites that participated in the pivotal
SPEARHEAD-1 trial
FDA GMP Pre-license inspections (PLI) have taken place at the Company’s Navy Yard facility and at the lentiviral vector contract manufacturer’s facility
Preliminary plans for confirmatory evidence for afami-cel’s full approval were previously agreed with FDA, including Cohort 2
Adaptimmune expects to discuss post-marketing requirements and commitments at the late-cycle meeting which is scheduled for the second half of May
To date, the FDA has not requested an Advisory Committee meeting or a REMS program
The marketing application for the companion diagnostic for MAGE-A4 is currently under FDA review and is expected to be approved contemporaneously with the BLA
Adaptimmune is preparing to launch afami-cel on approval in the U.S. Initially, launch will be focused on 6-10 selected treatment centers ("Authorized Treatment Centers" or "ATCs") and will expand to up to ~30 ATCs.
100% of the customer facing commercial and medical affairs teams is now in place
Company launched www.Tcrtcell.com: an unbranded website aimed at educating healthcare providers about TCR T-cell therapy in solid tumors, including synovial sarcoma, and the role of biomarkers and testing to determine future treatments
The second product in Adaptimmune’s sarcoma franchise, lete-cel, is being investigated in the pivotal IGNYTE-ESO trial (NCT03967223), which at a planned interim analysis exhibited response in 18/45 of patients (ORR 40%). The primary efficacy endpoint requires 16/60 patients have responses, so this trial has met its primary endpoint for efficacy. The full pivotal analyses are anticipated in late 2024.
Lete-cel will enable Adaptimmune to expand its addressable synovial sarcoma patient population by targeting the NY-ESO cancer antigen, in addition to MAGE-A4 targeted by afami-cel, as well as treating Myxoid Round Cell Liposarcoma (MRCLS) patients.
Sarcoma franchise of afami-cel and lete-cel leverages same development and commercial footprint with US peak year sales projected to be up to $400 million
Data presentations
Data from pivotal SPEARHEAD-1 trial with afami-cel published in The Lancet: article entitled "Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): an international, open-label, phase 2 trial"
Data from the planned interim analysis of the pivotal IGNYTE-ESO trial with lete-cel to be presented by Dr. Sandra P. D’Angelo, M.D., Sarcoma Medical Oncology, Memorial Sloan Kettering Cancer Center, in an oral presentation at ASCO (Free ASCO Whitepaper) entitled "Lete-cel in patients with synovial sarcoma or myxoid/round cell liposarcoma: Planned interim analysis of the pivotal IGNYTE-ESO trial" during the Developmental Therapeutics-Immunotherapy session in Hall D2 on June 3, 2024 at 11:30 a.m. CDT
Clinical pipeline

Uzatresgene autoleucel ("uza-cel", formerly ADP-A2M4CD8) is being investigated in the SURPASS-3 Phase 2 clinical trial (NCT05601752) for the treatment of platinum-resistant ovarian cancer. Uza-cel received FDA RMAT designation in 2022 for the treatment of patients with platinum resistant ovarian cancer. The SURPASS-3 trial is currently enrolling patients.
Cohorts in the Phase 1 SURPASS trial are ongoing for people with head & neck and urothelial (bladder) cancers with uza-cel in combination with standard of care checkpoint inhibitor therapy.
Preclinical pipeline

IND-enabling studies are underway for ADP-600 (PRAME) and ADP-520 (CD70) programs.
Wholly owned allogeneic pipeline advancing; process development in progress at Adaptimmune’s allogeneic manufacturing facility in Milton Park, UK.
Data presentation
Poster presented by George Pope, Ph.D., Associate Director Preclinical Safety at Adaptimmune, entitled "Development and Preclinical Characterization of an Engineered T-Cell Therapy Targeting PRAME-Expressing Solid Tumors" at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual meeting
Corporate news

As announced earlier today, Adaptimmune has secured up to $125 million in debt financing with Hercules Capital with the first tranche of $25 million available upon closing; and an additional $25 million available upon afami-cel approval
Cash runway into late 2025 which includes current cash on hand, anticipated revenues from the launch of afami-cel, expected future income from partners and other non-dilutive capital sources including the Company’s new debt facility with Hercules Capital
Company announced that its strategic collaboration with Genentech was terminated
Financial Results for the three months ended March 31, 2024

Cash / liquidity position: As of March 31, 2024, Adaptimmune had cash and cash equivalents of $140.7 million and Total Liquidity[1] of $143.7 million, compared to $144.0 million and $146.9 million respectively, as of December 31, 2023.
Revenue: Revenue for the three months ended March 31, 2024, was $5.7 million compared to $47.6 million for the same period in 2023. Revenue has decreased in 2024, compared to the same period in 2023 primarily due to the termination of the Astellas collaboration in the first quarter of 2023, resulting in the remaining deferred income for the collaboration being recognized as revenue in March 2023.
Research and development (R&D) expenses: R&D expenses for the three months ended March 31, 2024, were $35.2 million compared to $25.5 million for the same period in 2023. R&D expenses in the three months ended March 31, 2024 increased in employee-related costs and additional costs associated with lease properties following the acquisition of TCR2 in June 2023 and a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits.
General and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2024, were $19.7 million compared to $20.4 million for the same period in 2023. G&A expenses in the three months ended March 31, 2024 decreased due to restructuring and charges recognised in the first quarter of 2023 and a decrease in other corporate costs due to an increase in accounting, legal and professional fees incurred in relation to the TCR2 Therapeutics, Inc merger agreement that were not repeated in 2024, offset by an increase in depreciation due to leasehold improvements capitalised in 2023.
Net loss/profit: Net loss attributable to holders of the Company’s ordinary shares for the three months March 31, 2024, was $48.5 million ($(0.03) per ordinary share), compared to a profit of $1.0 million ($0.00 per ordinary share), for the same periods in 2023.
Financial Guidance
The Company believes that its existing cash, cash equivalents and marketable securities, together with anticipated revenues from the launch of afami-cel, expected future income from partners and other non-dilutive capital sources including the Company’s new debt facility with Hercules Capital announced earlier today, will fund the Company’s current operations into late 2025, as further detailed in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2024, to be filed with the Securities and Exchange Commission following this earnings release.

Adaptimmune Secures up to $125 Million Debt Financing with Hercules Capital

On May 15, 2024 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, reported that it has entered into a $125 million five-year, term loan facility with Hercules Capital, Inc. (NYSE: HTGC) ("Hercules") (Press release, Adaptimmune, MAY 15, 2024, View Source [SID1234643360]). The transaction strengthens the Company’s balance sheet as it executes on its sarcoma franchise with the commercial launch of afami-cel later this year and lete-cel planned for 2026. The Company will host a live webcast at 8:00 a.m. EDT (1:00 p.m. BST) today to report its Q1 financial and business updates.

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Gavin Wood, Adaptimmune’s Chief Financial Officer: "We are focused on getting products to market starting with afami-cel later this year. We know that afami-cel has the potential to make a tremendous difference for people with sarcoma and we are pleased to partner with Hercules Capital in this transaction to strengthen our balance sheet."

R. Bryan Jadot – Senior Managing Director and Group Head at Hercules Capital: "Hercules is excited to partner with Adaptimmune as they prepare to launch afami-cel and bring this therapy to patients living with synovial sarcoma. We are proud to support Adaptimmune’s mission to design and deliver cell therapies to transform the lives of people with cancer."

Jeffrey Ralto – Principal at Hercules Capital: "We are proud to support Adaptimmune mission of developing and commercializing treatments for people with cancer. This financing should help support Adaptimmune’s clinical and commercial strategies."

The term loan facility provides for up to $125 million of term loans in aggregate, available in up to five tranches. Upon closing of the transaction, the first tranche of $25 million can be drawn. Under the terms of the agreement, Adaptimmune will be eligible to draw an additional tranche of $25 million upon afami-cel approval, and three additional tranches totaling $75 million over the medium-term subject to certain conditions.

Additional details of the loan agreement will be filed with the Securities and Exchange Commission on a Current Report on Form 8-K.

TD Cowen acted as sole financial advisor to the Company. Ropes & Gray served as legal counsel to Adaptimmune and DLA Piper served as legal counsel to Hercules.

Today’s Webcast Details for Adaptimmune’s Q1 financial and business updates
A live webcast and replay can be accessed at View Source Call in information is as follows: 1-800-806-5484 (US or Canada) or +416-340-2217 (International and additional options available HERE) and the passcode is 3025919#. Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.

Molecular Templates, Inc. Reports First Quarter 2024 Financial Results and Corporate Update

On May 15, 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 first quarter of 2024 (Press release, Molecular Templates, MAY 15, 2024, View Source [SID1234643358]).

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Recent Company Highlights

MTEM presented clinical data at the 2024 AACR (Free AACR Whitepaper) Annual Meeting that demonstrated MT-6402’s tolerable safety and promising efficacy profile in relapsed/refractory HNSCC patients. As monotherapy in 7 evaluable HNSCC patients (all heavily pretreated and checkpoint experienced), 2 confirmed PRs (ongoing at 10 and 20 months, respectively) and 4 SDs (two of whom showed tumor reduction) were observed. An expansion cohort in relapsed/refractory HNSCC with MT-6402 monotherapy is underway with data expected by year-end. A second monotherapy MT-6402 expansion cohort is enrolling for solid tumor patients with high PD-L1 (≥ 50%).
The MT-8421 Phase 1 dose escalation is ongoing with continued observation of unique pharmacodynamic profile (peripheral and TME Treg depletion)
In April, MTEM completed the second closing of the July 2023 financing with gross proceeds of approximately $9.5M
Eric Poma, PhD., Chief Executive and Chief Scientific Officer of MTEM, stated, "MT-6402 and MT-8421 represent novel approaches to validated immuno-oncology targets. Monotherapy activity with MT-6402 in patients that have progressed on available therapy, including checkpoint therapy, demonstrates the potential of our technology. We look forward to expanding on these promising data."

Conferences and Upcoming Meetings

MTEM will participate at the BIO International conference taking place at the San Diego Convention Center from June 3 – 6, 2024. One-on-one meetings may be scheduled by directly contacting Molecular Templates.

First Quarter 2024 Financial Results

The net income attributable to common shareholders for the first quarter of 2024 was $0.6 million, or $0.11 per basic share and $0.08 per diluted share. This compares with a net income attributable to common shareholders of $10.8 million, or $2.89 per basic and diluted share, for the same period in 2023.

Revenues for the first quarter of 2024 were $11.1 million, compared to $36.6 million for the same period in 2023.

Total research and development expenses for the first quarter of 2024 were $7.4 million, compared with $19.0 million for the same period in 2023. Total general and administrative expenses for the first quarter of 2024 were $3.7 million, compared with $5.8 million for the same period in 2023.

As of March 31, 2024, MTEM’s cash and cash equivalents totaled $6.8 million. The Company expects that its cash and cash equivalents for the quarter ended March 31, 2024, and the subsequent second closing of the July 2023 financing with gross proceeds of approximately $9.5M, 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
March 31,
2024
2023
Research and development revenue $ 10,924 $ 33,627
Grant revenue 162 3,002
Total revenue 11,086 36,629
Operating expenses:
Research and development 7,405 19,042
General and administrative 3,731 5,802
Total operating expenses 11,136 24,844
Income/(loss) from operations (50 ) 11,785
Interest and other income, net 109 455
Interest and other expense, net (31 ) (1,395 )
Change in valuation of contingent value right 544 —
Net income attributable to common stockholders $ 572 $ 10,845
Net income per share attributable to common stockholders:
Basic $ 0.11 $ 2.89
Diluted $ 0.08 $ 2.89
Weighted average number of shares used in net income per share calculations:
Basic 5,374,268 3,756,711
Diluted 7,015,864 3,756,711

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

March 31,
2024
(unaudited) December 31,
2023
ASSETS
Current assets:
Cash and cash equivalents $ 6,779 $ 11,523
Prepaid expenses 1,200 2,195
Grants revenue receivable 412 250
Other current assets 2,299 2,804
Total current assets 10,690 16,772
Operating lease right-of-use assets 8,647 9,161
Property and equipment, net 6,284 7,393
Other assets 1,498 2,057
Total assets $ 27,119 $ 35,383
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 2,681 $ 1,523
Accrued liabilities 2,748 4,279
Deferred revenue, current — 9,031
Other current liabilities 3,152 2,488
Total current liabilities 8,581 17,321
Operating lease liabilities, long term portion 9,075 9,742
Contingent value right liability 2,158 2,702
Other liabilities 1,435 1,406
Total liabilities 21,249 31,171
Commitments and contingencies
Stockholders’ equity
Preferred stock, $0.001 par value per share:
Authorized: 2,000,000 shares as of March 31, 2024 and December 31, 2023; Issued and outstanding: 250 shares as of March 31, 2024 and December 31, 2023 — —
Common stock, $0.001 par value per share:
Authorized: 150,000,000 shares as of March 31, 2024 and December 31, 2023; Issued and outstanding: 5,374,268 shares as of March 31, 2024 and December 31, 2023 5 5
Additional paid-in capital 458,185 457,099
Accumulated deficit (452,320 ) (452,892 )
Total stockholders’ equity 5,870 4,212
Total liabilities and stockholders’ equity $ 27,119 $ 35,383