On October 29, 2021 Sprint Bioscience reported the the third quarter was an intense and news-dense period (Press release, Sprint Bioscience, OCT 29, 2021, View Source [SID1234592191]). Thanks to a licensing agreement and a rights issue, the company now finds itself in its strongest financial position to date and ready to take the next step in its development. BioStock contacted CEO Erik Kinnman to get his view on the past quarter and on the future.

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With three outlicensed drug programs, with a combined potential value of 747 million USD, plus potential royalties, the future has a lot to offer Sprint Bioscience. The latest in the line of license deals is the immunooncology program Vps34. During the third quarter, the company worked intensely on handover to American Deciphera Pharmaceuticals, that is now taking over the helm in the program.

Solid base for continued investments
A brand new new license agreement and a completed rights issue mean that Sprint Bioscience stands at a cash position of 85.7 million SEK at the end of the third quarter, ready to invest further in new preclinical drug programs.

And the company has not been slow to make use of this. Shortly after Vps34 was outlicensed, the company announced the next addition to the internal development portfolio, NIMA. The goal of the project is to develop a treatment for solid cancerous tumours. The candidate aims to inhibit the tumour’s ability to program the microenvironment around it, thus preventing tumour growth and facilitating attacks from the immune system. You can read more about the program here.

Great interest in the development projects
In addition, progress has also been made in the DISA development program, where the intended target protein has been announced. In connection with this, the marketing of the program began, with intensified dialogues with potential licensees. A first stop on the marketing journey was the partnering conference BIO-Europe, which took place during the past week, where Sprint Bioscience was met with great interest in both DISA and other development programs.

In parallel with the escalating marketing of DISA, work is also ongoing to find new interesting starting points for more drug development programs. One such program is carried out in collaboration with Dr Julian Walfridsson at Karolinska Institutet, a program that was recently awarded a research grant of 2.5 million SEK from the Swedish Foundation for Strategic Research. Read more.

Björn Sjöstrand new Chairman of the Board
However, it was not only the coffers and portfolio that expanded during the quarter, Sprint Bioscience also took steps to strengthen the organisation. The company has appointed a new CFO in the form of Mattias Skalmstad and the board was joined by life science entrepreneur Björn Sjöstrand as its new chairman. You can read an interview with Sjöstrand where he talks about his entry into, and his view of, the company here.

CEO comments
Overall, it has been an eventful quarter for Sprint Bioscience. BioStock contacted the company’s CEO Erik Kinnman to get his view of the third quarter and to learn more about what he sees ahead as we move towards winter.

First of all, Erik, how would you like to sum up the past quarter?
– It’s been very intense and successful. We have outlicensed the VPS34 program to Deciphera Pharmaceuticals, a very strong partner that has already shown great commitment to taking the program further. This is our largest deal to date and together with the new share issue carried out in August, this means that we have greatly strengthened our financial position.

– With a strong financial position in place, we can look to the future and focus on continuing to develop the business and build values in both outlicensed and internal programs.

BIO-Europe was held this week, an important event for you where you had conversations about the DISA project. What is the interest in the project so far?
– There is a noticeable interest from a large number of different companies. Some are interested more generally in what we have to offer, others are more specifically interested in either the VADA or DISA programs. It is clear that the mechanisms we address are highly interesting. DISA is in the relatively early stages compared to the VADA programme and we have received valuable feedback and started new dialogues. The BIO-Europe meeting has been successful for us and provided us with good support for continued discussions and marketing of our pharmaceutical programs.

Looking ahead, what milestones do you see in the next year?
– We continue to work intensively with our partners and the outlicensed programs to reach the next milestone on the path to clinical development and market approval. Such successes will further validate our business model. Furthermore, we want to continue to build our internal portfolio of highly interesting cancer drug programs and we are constantly working to sign new licensing agreements with strong international partners.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

On October 29, 2021 Signet Therapeutics, a biopharmaceutical startup focusing on developing innovative targeted cancer drugs using novel disease models, reported it has completed seed-2 round of approximately 10 million US dollars (Press release, Signet Therapeutics, OCT 29, 2021, View Source [SID1234592207]).

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The new round was led by 5Y Capital (Morningside Venture), with participation from Yael Capital, Blue Ocean Capital, and existing investors Tiantu Capital and Sky9 Capital. The new funding will advance Signet’s two first-in-class oncology programs toward clinical trials. In addition, Signet plans to expand its platform of disease models to other cancer areas and empower target discovery and pharmacodynamics studies at other pharmaceutical companies on a greater scale. Founded in 2020, Signet has raised a seed round of ￥60 million in CNY (equivalent to approximately $10 million), totaling two rounds of around $20 million within its first year.

Dr. Haisheng Zhang, CEO of Signet Therapeutics, and his core team members were from Dana-Farber Cancer Institute, Harvard Medical School, one of the world’s leading cancer research institutions. Traditional in vitro studies use cell lines that cannot accurately model patient’s drug performance, often returning misleading bioactivity results that misguide the screening and optimization of lead compounds, which could result in clinical failure. Leveraging years of oncology and functional biology and genomic research expertise, Signet developed a unique platform of novel disease models based on real-world cancer genomics data to simulate drug effects in 3D organ tissues that bear a closer resemblance to human biology and produce pharmacodynamics data with higher relevance to clinical performance.

Gastric cancer is the third leading cause of cancer death in the world. Close to one-third of the cases are of the diffusive gastric cancer (DGC) subtype, which is associated with poor prognosis and a low response rate to existing cancer therapies and medicines. Using its novel disease models platform, Signet made the groundbreaking discovery of a promising new target for DGC. It launched a drug discovery program with the leading AI drug R&D company XtalPi and, in March 2021, announced the identification of a pre-clinical candidate in over six months.

As Signet quickly advance its first-in-class DGC pipeline toward clinical trials, it has recently expanded its drug discovery program with XtalPi to another novel cancer target discovered by Signet. The two companies hope to build upon their existing success in combining XtalPi’s AI drug discovery capabilities with Signet’s customized novel disease models to quickly discover and validate candidates with potent bioactivity and a desirable drug property profile that can translate to enhanced clinical performance.

On October 29, 2021 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) reported that it will host a conference call and live webcast on Monday, November 1, 2021, at 8:30 a.m. Eastern Time to report its third quarter 2021 financial results and recent portfolio execution (Press release, Kiniksa Pharmaceuticals, OCT 29, 2021, View Source [SID1234593969]).

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A live webcast will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours of the event. The conference call can be accessed by dialing (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 1699563.

On October 28, 2021 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases, reported recent corporate highlights and financial results for the quarter ended September 30, 2021 (Press release, Aldeyra Therapeutics, OCT 28, 2021, View Source [SID1234592088]).

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"We continue to make important progress in developing safe and effective treatments for ocular and systemic diseases to improve the lives of patients who have significant unmet medical needs," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "Among key clinical milestones, we expect to release top-line results from the Phase 3 TRANQUILITY and TRANQUILITY-2 dry eye disease clinical trials in the fourth quarter of this year and are on track to report top-line results from Phase 2 clinical trials of ADX-629 in psoriasis, atopic asthma, and COVID-19 by the end of the year or early 2022. We also look forward to the planned initiation of our Phase 2 clinical trial of ADX-2191 in retinitis pigmentosa this quarter."

Recent Corporate Highlights and Program Updates

Top-Line Results from the Phase 3 TRANQUILITY and TRANQUILITY-2 Trials in Dry Eye Disease Expected in the Fourth Quarter of 2021. Ocular redness is the primary endpoint of the TRANQUILITY trials, which include tear RASP levels, Schirmer’s test, and dry eye disease symptoms as secondary endpoints. In addition, enrollment has completed in a multi-center, double-masked, randomized, vehicle-controlled, parallel-group Phase 2 clinical trial of reproxalap in dry eye disease. The Phase 2 trial was designed to optimize the measurement of tear RASP levels.
Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa Scheduled to Initiate in the Fourth Quarter of 2021. The primary endpoint of the trial is the safety and tolerability of ADX-2191 in patients with retinitis pigmentosa. Secondary endpoints are visual acuity, central retinal sensitivity, dark-adapted retinal sensitivity, and retinal morphometry.
Phase 2 Clinical Trial Results from ADX-629, an Orally Administered RASP Inhibitor, Expected in the Fourth Quarter of 2021 or First Quarter of 2022. ADX-629 is in proof-of-concept Phase 2 clinical trials for the treatment of psoriasis, atopic asthma, and COVID-19. ADX-629 represents a first-in-class systems-based therapeutic approach for the potential treatment of many immune-mediated diseases that today are treated with single-target drugs that can lead to toxicity.
Post-Acute Ocular Tolerability Comparison of Topical Reproxalap 0.25% and Lifitegrast 5% in Patients with Dry Eye Disease Paper Published in Peer-Reviewed Journal. Clinical Ophthalmology published the results of a clinical trial comparing the subjective eye drop experience of patients with dry eye disease over one hour after a single dose of two formulations of reproxalap versus lifitegrast.
Third-Quarter 2021 Financial Results

Cash and cash equivalents as of September 30, 2021 were $241.4 million. Based on Aldeyra’s current operating plan, the company believes that existing cash and cash equivalents will be sufficient to fund currently projected operating expenses through the end of 2023, including potential New Drug Application submissions; initial commercialization of reproxalap, if approved; and continued development of the company’s product candidates in ocular and systemic immune-mediated diseases.

For the quarter ended September 30, 2021, Aldeyra reported a net loss of $15.8 million, compared with a net loss of $8.9 million for the quarter ended September 30, 2020. Net loss per share was $0.27 for the quarter ended September 30, 2021, compared with $0.23 for the same period in 2020. Losses have resulted from the costs of clinical trials and research and development programs, as well as from general and administrative expenses.

Research and development expenses were $12.9 million for the quarter ended September 30, 2021, compared with $6.1 million for the same period in 2020. The increase of $6.8 million is primarily related to increases in our clinical research and development expenditures and consulting costs, partially offset by decreases in personnel related costs, including stock-based compensation, and manufacturing activities.

General and administrative expenses were $2.5 million for the quarter ended September 30, 2021, compared with $2.3 million for the quarter ended September 30, 2020. The increase of $0.2 million is primarily due to an increase in miscellaneous administrative costs.

For the quarter ended September 30, 2021, total operating expenses were $15.4 million, compared with total operating expenses of $8.4 million for the same period in 2020.

Conference Call & Webcast Information

Aldeyra will host a conference call at 8:00 a.m. ET today to discuss third-quarter 2021 financial results and recent corporate highlights. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 8891298. Due to expected high demand, please dial in at least 15 minutes prior to the start time.

A live webcast of the conference call will also be available on the Investor Relations page of the company’s website at View Source After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

On October 28, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported an update on the ongoing development of its product candidates, eftilagimod alpha ("efti") and IMP761 for the quarter ended 30 September 2021 (Press release, Immutep, OCT 28, 2021, View Source [SID1234592105]).

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Efti Development Program for Cancer

AIPAC – Phase IIb clinical trial – ongoing
Immutep will report final Overall Survival (OS) data from its Phase IIb AIPAC clinical trial evaluating efti in metastatic breast cancer as a late breaker poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2021 taking place in the US and virtually from 10-14 November.

Immutep previously reported initial OS data from approximately 60% of events in December 2020 at the San Antonio Breast Cancer Symposium. The study reported a promising and improving trend in OS in the total population with a median survival benefit of +2.7 months from efti plus chemotherapy, compared to chemotherapy plus placebo. In addition, a statistically significant OS benefit was observed in the efti group in key pre-defined patient groups, including patients under 65 years of age and those with low starting monocyte count.

AIPAC-003 – Phase III – new
Immutep is continuing the preparation and planning steps for its Phase III clinical trial evaluating efti in patients with metastatic breast cancer.

TACTI-003 – Phase IIb clinical trial – new
In July 2021, Immutep completed all the necessary competent authority steps with the US Food and Drug Administration (FDA) and has received institutional review board approval to commence its Phase IIb TACTI-003 trial in the US. Recruitment has also opened in the Ukraine and more sites and countries will be added in the coming months. This follows the receipt of Fast Track designation in 1st line recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) from the US FDA in April 2021.

In addition, Immutep will be presenting the trial design for TACTI-003 via a poster at the SITC (Free SITC Whitepaper) 2021 conference in November.

TACTI-002 (also designated KEYNOTE-PN798) – Phase II clinical trial – ongoing
In September 2021, Immutep enrolled the last patient into Stage 2 of Part B of the Phase II TACTI-002 study, completing recruitment of 2nd line PD-1/PD-L1 refractory non-small cell lung cancer (NSCLC) patients into the trial. Recruitment is continuing for the additional 74 1st line NSCLC patients for the expansion of Part A, with 70 patients already enrolled. Recruitment for the expansion of Part A of the study continues to be ahead of the expected recruitment rate.

Immutep reported favourable interim Overall Response Rates (ORR) together with encouraging duration and depth of response in 1st line NSCLC (Part A) and 2nd line HNSCC (Part C) at ASCO (Free ASCO Whitepaper) in June 2021. The Company will report data from Part C of TACTI-002 at the SITC (Free SITC Whitepaper) 2021 conference in November. Additional data from this study trial are planned to be reported in the first half of calendar year 2022.

INSIGHT
INSIGHT is an investigator-initiated Phase I trial at the Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF) investigating different combination treatments with efti and a different route of administration for efti. INSIGHT consists of 5 different arms from stratums A to E.

INSIGHT-003 – triple combination
In August 2021, the first patient was enrolled and safely dosed in INSIGHT-003, also referred to as stratum C of INSIGHT. Patient recruitment is ongoing with 4 out of a total of 20 patients with various solid tumours now participating in the trial. First interim results are expected to be reported in 2022.

INSIGHT-004 – combination with avelumab
Results from INSIGHT-004 were presented at the ESMO (Free ESMO Whitepaper) Congress 2021 held 16-21 September. The results are in line with the previous poster presentation at ASCO (Free ASCO Whitepaper) 2021.

INSIGHT-005 – combination with bintrafusp alpha
INSIGHT-005, known as stratum E of INSIGHT, will involve 12 patients with solid tumours and will evaluate efti in combination with bintrafusp alfa. It will be conducted under Immutep’s collaboration agreement with Merck KGaA, Darmstadt, Germany.

Separately to Immutep’s ongoing collaboration agreement with Merck KGaA, Merck KGaA and GlaxoSmithKline announced a mutual decision to terminate their agreement to co-develop bintrafusp alfa. Accordingly, Immutep and Merck KGaA are working closely to determine the next steps for the INSIGHT-005 study.

EAT COVID – Phase II clinical trial – ongoing
The investigator-initiated EAT COVID study is continuing at the University Hospital Pilsen in the Czech Republic. Patient recruitment into the trial by the hospital has been slower than anticipated due to a significant decline in the number of infections and improving vaccination rates in the Czech Republic. The Company will provide an update on the trial in due course.

IMP761 Development Program for Autoimmune Disease

During the quarter, Immutep continued GMP manufacturing preparations for IMP761 and is planning for toxicology studies and other pre-clinical evaluations of this promising candidate.

Partnerships

EOC Pharma
Immutep’s Chinese partner for efti, EOC Pharma, announced it plans to expand its clinical trial pipeline for efti (designated EOC202 in China) in China. EOC is preparing to initiate a clinical study of efti in combination with an anti-PD-1 therapy in the first half of calendar year 2022. This new trial builds on EOC’s previously announced Phase II trial evaluating efti in combination with chemotherapy in metastatic breast cancer patients.

Novartis
Immutep’s partner, Novartis presented two posters at the ESMO (Free ESMO Whitepaper) Congress 2021. One poster included data from its PLATForM Phase II study of novel spartalizumab combinations in melanoma, concluding patients with LAG-3+ melanoma may be more likely to respond to spartalizumab + ieramilimab (LAG525) treatment.

Novartis also presented data from its Phase II, open-label, 3-arm study, in patients with advanced triple-negative breast cancer regardless of PD-L1 status progressing after adjuvant or one prior line of systemic therapy for metastatic disease, but who had not received an immune checkpoint inhibitor. Patients were randomised 1:1:1 to LAG525 + spartalizumab, LAG525 + spartalizumab + carboplatin, or LAG525 + carboplatin. As no arms of the study met the proof of preliminary efficacy criteria, no further investigation is planned for this study.

LAG525 is a humanised anti-LAG-3 antibody derived from Immutep’s IMP701 antibody, which is out-licensed to Novartis.

Intellectual Property

Immutep was granted three new patents relating to the protection of LAG525 (IMP701), which is fully out-licensed to Novartis, by the Chinese Patent Office, the Indian Patent Office and the Malaysian patent office during the quarter. The patents are co-owned by Novartis AG and Immutep SAS and follow the grant of the corresponding Australian, United States, European, and Japanese patents announced in 2018 through 2020.

Financial Summary – Q1 FY221

Cash receipts from customers for the quarter was $56k, compared to $10k in Q4 of FY21 (i.e. the quarter ended 30 June 2021).

The net cash used in G&A activities in the quarter was $1.01 million compared to $409k in Q4 FY21. The increase compared with last quarter is mainly due to capital raising related costs that were expensed in July 2021. Payments to Related Parties, detailed in Item 6 of the Appendix 4C cash flow report for the quarter includes $135k in payment of Non-Executive Director’s fees and Executive Director’s salary.

The net cash used in Research and Development activities in the quarter was $6.83 million, compared to $5.45 million in Q4 FY21. The significant increase is mainly due to increased clinical trial and manufacturing activities. Total net cash outflows used in operating activities in the quarter was $5.37 million. In comparison, total net cash outflows from operating activities in Q4 FY21 was $5.71 million.

Immutep received a €2,126,617 (~$3.42 million) research and development (R&D) tax incentive payment in cash from the French Government under its Crédit d’Impôt Recherche scheme (CIR) during the quarter in respect of expenditure incurred during calendar year 2020 on eligible R&D activities conducted in the European Union.

As part of the Company’s two-tranche financing announced in June 2021, shareholders approved the second tranche of an institutional placement of shares at the Company’s Extraordinary General Meeting in July 2021. The second tranche of the institutional placement raised $46.3 million. In total, Immutep raised $60 million via the institutional placement, which was supported by multiple institutional investors in Australia and offshore.

A further $7.2 million was raised from a Share Purchase Plan (SPP) completed in July 2021, which enabled existing eligible shareholders to participate in the financing on the same terms as the institutional placement. Due to strong demand from eligible shareholders, the amount raised exceeded the targeted amount sought to be raised ($5 million) under the SPP.

The Company’s cash and cash equivalent balance as at 30 September 2021 was $106.39 million compared to a balance of $60.59 million as at 30 June 2021. The enhanced cash balance puts the company in a strong financial position with an estimated cash reach of December 2023.

A copy of the Appendix 4C – Quarterly Cash Flow Report for the quarter is attached.