On May 16, 2022 InDex Pharmaceuticals Holding AB (publ) reported that interim report January – March 2022 (Press release, InDex Pharmaceuticals, MAY 16, 2022, View Source [SID1234614591])

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Period January – March 2022
Net sales amounted to SEK 0.0 (0.0) million
Operating loss amounted to SEK –18.9 (–9.3) million
Result after tax amounted to SEK –18.9 (–9.3) million, corresponding to SEK –0.04 per share (–0.02) before and after dilution
Cash flow from operating activities amounted to SEK –18.4 (–8.5) million
Cash and cash equivalents at the end of the period amounted to SEK 417.5 (532.5) million
Number of employees at the end of the period was 9 (7)
Number of shares at the end of the period was 532,687,650
All comparative amounts in brackets refer to the outcome during the corresponding period 2021.

Significant events during the quarter
InDex is planning for self-commercialisation of the drug candidate cobitolimod in the US with strategic collaborations in other regions
Significant events after the reporting period
Peter Zerhouni stepped down as CEO of InDex
Other events
InDex hosted a Capital Markets Day for investors, analysts and media
CEO statement
We are working intensively with the phase III study CONCLUDE. The study evaluates the drug candidate cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis. We are making great progress with the process of obtaining approval to start the study in the participating countries, where the study is currently approved by the regulatory authorities in 27 out of the around 30 planned countries. In addition, we see that more and more clinics are starting to screen and randomise patients. The clinics are now also starting to open up for external visits and we will continue our successful strategy of visiting the participating clinics together with Parexel.

To inform about cobitolimod and the phase III study CONCLUDE, InDex will participate with a booth at Digestive Disease Week (DDW), which is the premier medical congress in the world in gastroenterology. DDW takes place on May 21-24 in San Diego, USA and annually attracts over 10,000 participants from more than 100 countries. DDW also provides good opportunities to update our business contacts as all leading companies in the field are attending.

I am very happy to welcome Eva Arlander as Chief Development Officer to InDex. Eva has extensive experience of drug development from senior positions at among others AstraZeneca, Medivir, Affibody and the Medical Products Agency. Eva will be part of InDex’s new management team together with myself, Chief Medical Officer Anders Bröijersén and Chief Scientific Officer Charlotte Admyre.

InDex has together with external experts analysed the commercialisation options for cobitolimod in the US and Europe. The conclusion is that the market potential, the required commercial footprint, and the profitability profile in the US respectively are well suited for self-commercialisation by a focused commercial organisation to be built closer to launch. The US accounts for approximately 65% of the global market for ulcerative colitis. The fragmented European market, as well as other regions, offer attractive opportunities to enter strategic collaborations as cobitolimod advances towards launch. These conclusions were presented at our well-received Capital Markets Day in mid-March. We are happy that so many have had the opportunity to watch the presentations, both live and afterwards via the recording on our website.

I also would like to take the opportunity to highlight the annual report for 2021, which was published in the beginning of April. It provides a good overview of ulcerative colitis, cobitolimod, the phase III study CONCLUDE and the company’s other activities. We have also this year included a moving patient interview. This time with Sofie, who has lived with ulcerative colitis for 18 years and who really confirms the need for new effective and safe therapies for her and other patients suffering from ulcerative colitis.

On June 1 we have the annual general meeting in InDex, which also this year will be conducted through advance voting. The day after, on June 2, I will present the company at Redeye Growth Day and I hope to see you there.

Johan Giléus, acting CEO

Chairman statement
InDex is in an exciting and important phase, and I look at the future with great optimism. The company’s focus is on the implementation of the phase III study CONCLUDE with cobitolimod, which is progressing according to plan. Phase III is the final stage of development before application for market approval by the regulatory authorities and CONCLUDE is thus a very important milestone for the company.

InDex has a new management team in place which, with its extensive competence and experience, will lead the company forward as we now take cobitolimod through phase III and towards the market. The recruitment of a new CEO is ongoing, and the Board is aiming to present a new permanent CEO in the near future.

Finally, I would like to express a big thank you to all the personnel at InDex, whose hard work and commitment make InDex the great company it is, with the aim of improving the lives of the patients suffering from this severe disease while creating significant value for our shareholders.

The full report is attached as a PDF and is available on the company’s website View Source

Publication
This information is information that InDex Pharmaceuticals Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication through the agency of the contact person set out above at 8:00 CET on May 16, 2022.

On May 16, 2022 Scholar Rock (NASDAQ: SRRK), a Phase 3 clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported financial results for the first quarter ended March 31, 2022 (Press release, Scholar Rock, MAY 16, 2022, View Source [SID1234614640]).

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Business Strategy & Update

Prioritize R&D Activities to Support Progression and Completion of the Apitegromab Phase 3 SAPPHIRE Trial in Spinal Muscular Atrophy. Scholar Rock is focusing its expertise in inhibiting the activation of latent growth factors on completing the Phase 2 TOPAZ extension clinical trial and the Phase 3 SAPPHIRE clinical trial, both of which are evaluating the potential of apitegromab to address motor function impairments in patients with spinal muscular atrophy (SMA). The SRK-181 program for the treatment of patients with solid tumors showing primary resistance to anti-PD-(L)1 therapy remains a priority with strategic value. While investment in the existing scientific platform continues, the Company is narrowing the scope of discovery programs it expects to pursue.
Focused Strategy to Increase Operational Efficiency, Reduce Cash Burn and Extend Runway. The Company reported a restructuring of its business to prioritize and focus on its clinical stage assets resulting in a reduction to its workforce by approximately 25%, in addition to the curtailment of previously planned hiring. The reduction in operating expenses relates to general and administrative spend and research activities related to earlier stage programs. In conjunction with the pipeline prioritization, these changes are expected to extend the cash runway into the fourth quarter of 2023.
"We are highly confident in the transformative potential of apitegromab based upon the Phase 2 TOPAZ data we have released to date. We look forward to presenting two-year extension trial data in the coming weeks," said Nagesh Mahanthappa, Ph.D., Founding Chief Executive Officer of Scholar Rock. "Based upon the strength of the data released to date and our commitment to the SMA community, this narrower focus and associated headcount reduction is necessary to execute our core mission — completing the Phase 3 SAPPHIRE trial to bring apitegromab, our highly innovative therapeutic candidate, to patients suffering with this devastating disease."

Dr. Mahanthappa continued, "Parting with employees who have dedicated their talent and expertise to evolving a scientific platform into a Phase 3-stage company is very difficult, and we are extremely grateful for their contributions to our mission to support patients and help position us to potentially deliver the next big innovation to patients with SMA."

Changes to Development Leadership

The Company also announced today that Yung Chyung, M.D. has decided to step down as Chief Medical Officer (CMO) to explore new career opportunities, including his interest in global health. Dr. Chyung will remain with Scholar Rock through June 30 to work with the executive team and the development organization on a transition plan, and a retained search for a new CMO is ongoing.

"I am incredibly proud of the progress we’ve achieved to date at Scholar Rock and am humbled to have served alongside the amazing and talented employees across the company," said Dr. Chyung. "I am enthusiastic about the potential of apitegromab and SRK-181 to transform the lives of individuals impacted by serious diseases. With operational momentum continuing to build and the outstanding, high performing teams in place, I feel this is an appropriate time for me to explore my other long-term career interests, such as global health."

"The Board and I sincerely thank Yung for his ingenuity and leadership over the years, which have brought the apitegromab program forward through a successful Phase 2 proof-of-concept study and now into Phase 3, creating hope for patients and families suffering from SMA that muscle-directed therapy could have the potential to make a meaningful impact on their lives," said Dr. Mahanthappa. "While the search for a new CMO is a top priority and we are committed to identifying a medical leader with a strong track record in late-stage drug development and product launch, the significant depth of talent in our development team allows us to continue to build momentum in the SAPPHIRE pivotal and Phase 1 DRAGON proof-of-concept clinical trials without disruption."

Pipeline Updates

Apitegromab is a selective inhibitor of myostatin activation being developed as the potential first muscle-directed therapy for the treatment of spinal muscular atrophy (SMA).

Enrollment Ongoing for Phase 3 SAPPHIRE Clinical Trial Evaluating Apitegromab in Patients with Non-Ambulatory Type 2 and 3 SMA. The randomized, double-blind, placebo-controlled Phase 3 SAPPHIRE clinical trial is evaluating apitegromab for patients on either nusinersen or risdiplam. The clinical trial design plans for approximately 156 patients aged 2-12 years old with non-ambulatory Type 2 and 3 SMA to be enrolled in the main efficacy population.
Clinical Data from the Phase 2 TOPAZ 24-Month Extension Trial to be Presented at Cure SMA Annual Meeting in June.
Data from the Phase 2 TOPAZ Trial Presented at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference and the American Academy of Neurology Annual Meeting in March, as well as the European Paediatric Neurology Society Congress in April.
SRK-181 is a selective inhibitor of latent TGFβ1 activation being developed with the aim of overcoming primary resistance to and increasing the number of patients who may benefit from checkpoint inhibitor therapy.

Enrollment Ongoing for Part B of the Phase 1 DRAGON POC Clinical Trial for SRK-181. Part B consists of multiple proof-of-concept cohorts focused upon evaluating the ability of SRK-181 to overcome primary resistance to anti-PD-(L)1 therapy. Each cohort will enroll up to 40 patients with various solid tumors, including urothelial carcinoma (UC), cutaneous melanoma (MEL), non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma (ccRCC), and other solid tumors. The biomarker strategy in part B of DRAGON will explore early signs of SRK-181 activity, including target engagement and pathway modulation. This will include measuring effects on both circulating and tumor immune contexture, such as CD8+ T cell infiltration and reductions in myeloid-derived suppressor cell (MDSC) populations as well as analysis of TGFβ-related pathway signaling. Initial evidence of drug activity and safety data are anticipated in 2022.
First Quarter 2022 Financial Results

For the quarter ended March 31, 2022, net loss was $8.0 million or $0.21 per share compared to a net loss of $27.7 million or $0.76 per share for the quarter ended March 31, 2021.

Revenue was $33.2 million for the quarter ended March 31, 2022 compared to $4.7 million for the quarter ended March 31, 2021 and was related to the Gilead fibrosis-focused research collaboration, which was executed in December 2018 and concluded in December 2021.
Research and development expense was $29.4 million for the quarter ended March 31, 2022 compared to $22.5 million for the quarter ended March 31, 2021. The increase year-over-year primarily reflects increased clinical costs associated with apitegromab and higher personnel costs. The Company expects research expenses to decline beginning in the third quarter of 2022 due to the portfolio updates and workforce reduction announced today.
General and administrative expense was $10.8 million for the quarter ended March 31, 2022 compared to $9.4 million for the quarter ended March 31, 2021. The increase year-over-year was primarily attributed to higher personnel costs. As a result of our reduction in force, we expect our employee-related expenses to decline in the second half of the year as compared to the first half of 2022.
As of March 31, 2022, Scholar Rock had cash, cash equivalents, and marketable securities of approximately $210 million. The Company expects that the updates and changes announced today will fund its anticipated operating and capital expenditure requirements into the fourth quarter of 2023.
"While we have paused many of our discovery programs, we are continuing to progress selected pre-clinical programs which best exemplify the value of our platform. As a platform company, business development remains an important part of our strategy and we continue to explore partnerships for these programs which could be a source of non-dilutive capital in the future," said Ted Myles, Chief Operating Officer and Chief Financial Officer at Scholar Rock. "Our streamlined focus and structure allow us to channel the majority of our resources to supporting the SAPPHIRE trial and SRK-181, which we believe are key near- and long-term value drivers."

On May 16, 2022 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company reported financial results for the first quarter ended March 31, 2022 (Press release, Alaunos Therapeutics, MAY 16, 2022, View Source [SID1234614656]).

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"Dosing of the first patient in our TCR-T Library Phase 1/2 trial speaks to the dedication of our entire team and reaffirms our commitment to execution. We are working to continue enrolling patients in the trial and expect to provide an initial look at data later this year," commented Kevin S. Boyle, Sr., Chief Executive Officer. "We are honored to have two posters supporting our TCR-T platform targeting solid tumors at the upcoming ASGCT (Free ASGCT Whitepaper) and ASCO (Free ASCO Whitepaper) conferences. We believe we have positioned Alaunos for success and look forward to continued progress."

Recent Developments and Upcoming Milestones

TCR-T Library Trial: In May 2022, the Company announced that it had dosed the first patient with non-viral TCR-T cells in its TCR-T Library Phase 1/2 trial targeting KRAS, TP53, and EGFR mutations across six solid tumor indications. This is a major milestone for Alaunos as it also represents the first clinical product manufactured and administered to a patient using the Company’s in house cGMP manufacturing facility.

The study is being conducted at The University of Texas MD Anderson Cancer Center and is an open label, dose escalation study, with patients to be treated in one of three dosing cohorts: 5×109, 4×1010, or 1×1011 TCR-T cells. The trial is enrolling patients with non-small cell lung, colorectal, endometrial, pancreatic, ovarian, and bile duct cancers that have a matching human leukocyte antigen (HLA) and hotspot mutation pairing in Alaunos’ TCR-T library. The main study objectives are to define the maximum tolerated dose, recommended phase 2 dose and safety profile. The Company will present a trial in progress poster at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and expects to report initial data in the second half of 2022. Additional information about the study is available at www.clinicaltrials.gov using the identifier: NCT05194735.

Presenting preclinical data supporting membrane bound IL-15 (mbIL-15) at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting: Today, the Company will present preclinical data for its mbIL-15 program at the ASGCT (Free ASGCT Whitepaper) 25th Annual Meeting. The poster titled, "Stem-cell memory TCR-T cells targeting hotspot EGFR, KRAS and p53 neoantigens generated through co-expression of membrane-bound Interleukin-15" highlights the potential of mbIL-15 to establish long-lived tumor-specific TCR-T cells. The Company intends to file an IND application for this program in the second half of 2023.

First Quarter Ended March 31, 2022 Financial Results

Research and Development Expenses: Research and development expenses were $5.6 million for the first quarter of 2022, compared to $13.3 million for the first quarter of 2021, a decrease of approximately 58%. The decrease was primarily due to lower program-related costs as a result of the winding down of our IL-12 and CAR-T programs and lower employee related expenses due to our reduced headcount following our strategic restructuring event in the third quarter of 2021.

General and Administrative Expenses: General and administrative expenses were $3.5 million for the first quarter of 2022, compared to $8.2 million for the first quarter of 2021, a decrease of approximately 57%. The decrease was primarily due to lower employee related expenses due to our reduced headcount following our strategic restructuring event in the third quarter of 2021 and a decrease in consulting and professional services expenses.

Net Loss: Net loss was $9.8 million, or $(0.05) per share, for the first quarter of 2022, compared to a net loss of $21.6 million, or $(0.10) per share, for the same period in 2021.

Cash and Cash Equivalents: As of March 31, 2022, Alaunos had approximately $68.3 million in cash and cash equivalents. The Company anticipates its cash runway will be sufficient to fund operations into the second quarter of 2023. Operating cash burn for the first quarter of 2022 was $7.8 million compared to $15.3 million in the first quarter of 2021, a decrease of $7.5 million or 49%.

Conference Call and Webcast

The conference call can be accessed by dialing 844-309-0618 (United States) or 661-378-9465 (International) with the conference code 2495623. A live webcast may be accessed using the link here, or by visiting the "Investors" section of the Alaunos website at www.alaunos.com. After the live webcast, the event will be archived on the Company’s website for approximately 30 days after the call.

On May 16, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported details of the initial clinical trial in the Company’s pan-cancer Fibroblast Activation Protein-α (FAP-α) targeted program PNT2004, FRONTIER (Press release, Point Biopharma, MAY 16, 2022, View Source [SID1234614672]).

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FRONTIER stands for "FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients with Select Solid Tumors".

The Phase 1 clinical trial is expected to commence in summer 2022 in Canada and will use a gallium-68 (68Ga)-based PNT6555 molecular imaging agent to select patients to receive a no-carrier-added (n.c.a.) lutetium-177 (177Lu)-based PNT6555 therapeutic agent. The Phase 1 clinical protocol will evaluate PNT6555 in ~30 patients in five FAP-avid cancer indications: colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcoma.

Dosing will start at 4 GBq with each subsequent dose level increasing by 4 GBq and 2 GBq dose de-escalations. Each 177Lu PNT6555 dose will be followed by a 6-week interval. 68Ga-PNT6555 PET/CT imaging will be conducted approximately 90 minutes post injection, and dosimetry will be completed at the time of first 177Lu-PNT6555 dose and each subsequent cycle. The primary objective of the study is to determine the maximum tolerated dose (MTD), and the Recommended Phase II Dose (RP2D). The company expects to present initial imaging and dosimetry data in early 2023.

"We believe radiopharmaceuticals are on the verge of a revolution," said Dr. Joe McCann, CEO of POINT Biopharma. "For most of their existence, therapeutic radio-pharmaceuticals have been limited to small, orphan indications. Drug candidates like PNT6555 could exponentially increase the number of patients which could benefit from this treatment modality. FAP-α is an extremely exciting target for therapeutics. It is present in greater than 90% of epithelial tumors, which include many of the highest prevalence forms of cancer. Not only would better imaging to detect metastatic dis-ease enable more cancers to be treated earlier, but the capability of delivering radiation directly to a wide variety of cancers could also revolutionize treatment paradigms."

FRONTIER will be the first in-human trial of PNT6555, while additional preclinical studies are in development and include other therapeutic isotopes such as actinium-225 (225Ac). A summary of the pre-clinical data for the program can be found in a poster presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting last month, titled "Pre-clinical characterization of the novel Fibroblast Activation Protein (FAP) targeting ligand PNT6555 for the imaging and therapy of cancer" (Abstract ID: 3554, Session: Preclinical Radiotherapeutics). The presented data conclude:

• In pre-clinical xenograft models: 68Ga-PNT6555 is an effective imaging agent, with strong tumor targeting, low background in normal tissues and rapid clearance via urinary excretion, and 177Lu-PNT6555 shows prolonged tumor retention out to 168 hours post-injection.

• Efficacy studies with 177Lu-PNT6555 or 225Ac-PNT6555 demonstrate compelling and dose-responsive inhibition of HEK-mFAP tumor growth.

A link to the poster can be found on the Investor Presentations section of the Company’s website: View Source

On May 16, 2022 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for allergy, opioid overdose, respiratory and inflammatory disease, reported financial results for the quarter ending March 31, 2022 (Press release, Adamis Pharmaceuticals, MAY 16, 2022, View Source [SID1234614699]).

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Product and Pipeline Updates and Other Corporate Developments

ZIMHI

·According to the Centers for Disease Control and Prevention (CDC), drug overdoses resulted in over 108,000 deaths in the U.S. over the most recent 12 months of data. Two thirds of these involved fentanyl.

·Our U.S. commercial partner, US WorldMeds, commercially launched our high dose naloxone product, ZIMHI, at the end of March.

·We are encouraged by the early acceptance of ZIMHI in the market.

SYMJEPI

·In March, Adamis announced a voluntary recall of certain lots of SYMJEPI.

·Manufacturing of SYMJEPI has been on hold pending the results of an investigation to determine the root cause. The Company believes the investigation is nearing completion, that a root cause relating to a particular batch of syringe needles has been identified, and that corrective and preventive actions have been and will be taken.

·We anticipate a resolution and resumption of manufacturing after those issues are satisfactorily addressed, which we believe will occur during the second quarter.

TEMPOL

·The Company’s Phase 2/3 clinical trial of Tempol as a treatment for COVID-19 is continuing.

·In March, the Data Safety Monitoring Board (DSMB) overseeing the Tempol trial met to evaluate the clinical and safety data from the first planned interim analysis and, following their evaluation, recommended the study continue without modification.

·The DSMB plans to meet again, anticipated to be at the end of May or in June, to review interim data analysis for the first 124 patients.

·In addition to the work in COVID, the Company continues to explore additional indications for the use of Tempol including, but not limited to, asthma and long COVID.

Financial Results

Revenues for the quarters ending March 31, 2022 and 2021 were approximately $1.2 million and $1.4 million, respectively. Revenues for the quarter ended March 31, 2022 consisted mainly of approximately $1.1 million of sales of ZIMHI to our commercial partner US WorldMeds in anticipation of the commercial launch of ZIMHI announced at the end of March. Due to the SYMJEPI manufacturing hold and the voluntary recall of certain lots, no revenues relating to SYMJEPI were reported for the first quarter of 2022.

Selling, general and administrative expenses for the quarters ending March 31, 2022 and 2021 were approximately $3.4 million and $3.5 million, respectively. SG&A expenses in the first quarter of 2022 reflected a decrease in legal and compensation expenses, offset by an increase in accounting and finance related expenses.

Research and development expenses were approximately $4.2 million and $2.2 million for the first quarter of 2022 and 2021, respectively. The increase was primarily due to expenses relating to the ongoing clinical trial for our Tempol product candidate.

Net loss from discontinued operations for the three months ended March 31, 2022 and 2021 was approximately $165,000 and approximately $1.5 million, respectively. The decrease in loss was primarily attributable to the winding down and cessation of US Compounding’s operations.

Cash and cash equivalents at March 31, 2022, totaled approximately $17.8 million. For this year, we expect to receive additional proceeds resulting from amounts payable to us pursuant to our sale of certain USC assets to Fagron and from the disposition of the remaining USC assets which includes the land, the building, the machinery and the equipment.

Conference Call

Adamis will host a conference call and live webcast today, May 16, 2022, at 2 p.m. PT (5 p.m. ET) to discuss its financial and operating results for the first quarter 2022, as well as provide an update on business developments and activities.

A live audio webcast of the conference call will also be available via this link. If you are unable to participate in the live call, a replay will be available shortly after the live event. To listen to the replay please visit the events page of the Adamis investor relations section of the company website at View Source