On May 11, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T-cell activating technologies, reported that it will discuss its financial results for the quarter ended March 31, 2022, and provide a business update on its conference call today (Press release, PDS Biotechnology, MAY 11, 2022, View Source [SID1234614181]).

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"2022 is shaping up to be an incredibly productive year for PDS Biotech," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of the Company. "As we continue to make significant clinical progress on our lead oncology candidate, PDS0101, we’re looking ahead to presentations of preliminary data from our two most advanced Phase 2 clinical trials at this year’s ASCO (Free ASCO Whitepaper) meeting in early June. We believe ASCO (Free ASCO Whitepaper)’s selection of the preliminary data from both trials for presentation at the June meeting is a testament to the quality of work being done by our team and our partners, as well as the potential demonstrated by PDS0101 in treating advanced HPV-associated cancers. We look forward to sharing these efficacy and safety data in the near term. In addition, we continue to leverage our proprietary platforms to advance our pre-clinical pipeline into clinical studies, focused on a variety of cancer targets and infectious diseases. Lastly, due to our partnering model and our financial discipline, we finished the quarter with a strong cash balance which we project to fund our current operations into 2024."

Recent Business Highlights:

Announced two abstracts accepted for poster presentation during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7 in Chicago:

The poster presentation of Abstract # 6041 will summarize updates to the preliminary efficacy and safety data from the PDS-sponsored VERSATILE-002 Phase 2 clinical trial, which is evaluating PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.

The poster presentation of Abstract # 2518 will summarize updates from last year’s ASCO (Free ASCO Whitepaper) presentation to efficacy and survival data, as well as new findings from the ongoing National Cancer Institute (NCI)-led Triple Combination Phase 2 clinical trial. This trial is evaluating PDS0101 in combination with two investigational immune-modulating agents across the range of HPV16-positive advanced relapsed refractory cancers.

In April, received $1.2 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2021.

Announced that the NCI achieved the enrollment objective of 30 patients in the checkpoint inhibitor (CPI) refractory arm of the Triple Combination Phase 2 clinical trial for PDS0101.

First Quarter 2022 Financial Results
PDS Biotech reported a net loss of approximately $8.5 million, or $0.32 per basic share and diluted share, for the three months ended March 31, 2022 compared to a net loss of approximately $3.0 million, or $0.14 per basic share and diluted share, for the three months ended March 31, 2021.

Research and development (R&D) expenses increased to approximately $5.2 million for the three months ended March 31, 2022 from approximately $1.4 million for the three months ended March 31, 2021. The increase of approximately $3.7 million in 2022 was primarily attributable to an increase of $1.8 million in manufacturing services and quality costs, $1.04 million in clinical study and regulatory costs, $0.8 million in personnel costs and $0.06 million in facilities.

General and administrative expenses increased to approximately $3.3 million for the three months ended March 31, 2022 from approximately $1.6 million for the three months ended March 31, 2021. The increase of approximately $1.7 million is primarily attributable to an increase of $1.0 million in personnel costs, $0.6 million in legal fees and $0.1 in marketing expenses.

Total operating expenses increased to approximately $8.5 million for the three months ended March 31, 2022 from approximately $3.0 million for the three months ended March 31, 2021 for the reasons described above.

PDS Biotech’s cash balance as of March 31, 2022 was approximately $58.9 million.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM EDT on Wednesday, May 11, 2022. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13728184. To access the webcast, please use the following link PDS Biotech Earnings Webcast. The event will be archived in the investor relations section of PDS Biotech’s website for six months.

On May 11, 2022 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported results from its phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, MAY 11, 2022, View Source [SID1234614178]). The study did not meet its co-primary endpoint of progression-free survival. At this first analysis, the other co-primary endpoint of overall survival (OS) was immature, and the study will continue until the next planned analysis. A numerical improvement was observed in both co-primary endpoints. Data suggest that tiragolumab plus Tecentriq was well-tolerated and no new safety signals were identified when adding tiragolumab. Further analyses of these results are ongoing and data will be presented at an upcoming medical meeting.

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"While these results are not what we hoped for in our first analysis, we look forward to seeing mature overall survival for this study to determine next steps," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "We continue to believe that TIGIT may have a role in cancer treatment and we will share additional results from our tiragolumab programme as they emerge."

The tiragolumab programme continues to explore advances in multiple clinical trials to build on Tecentriq, expand into earlier stages of disease, and seeks to provide new treatment options in advanced and difficult-to-treat cancers with high unmet medical need.

About the SKYSCRAPER-01 study
SKYSCRAPER-01 is a global phase III, randomised double-blinded study evaluating tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone in 534 patients with first-line PD-L1-high locally advanced, unresectable or metastatic non-small cell lung cancer. Patients were randomized 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit or unacceptable toxicity. Co-primary endpoints are overall survival and progression-free survival.

About tiragolumab
Tiragolumab is an investigational novel immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint which suppresses the immune response to cancer.1 Based on preclinical research, tiragolumab is thought to work as an immune amplifier with other cancer immunotherapies such as Tecentriq (atezolizumab).2 The TIGIT pathway is distinct but complementary to the PD-L1/PD-1 pathway. Dual blockade with tiragolumab and Tecentriq may help overcome immune suppression and restore the immune response.1

About Tecentriq (atezolizumab)
Tecentriq is a cancer immunotherapy approved for some of the most aggressive and difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma. Tecentriq is also approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer and BRAF V600 mutation-positive advanced melanoma.

Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted therapies and various chemotherapies across a broad range of cancers. In addition to intravenous infusion, the formulation of Tecentriq is also being investigated as subcutaneous injection to hopefully provide a faster and more convenient option for cancer patients.

On May 11, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported the financial results and corporate updates for the first quarter 2022 (Press release, Evotec, MAY 11, 2022, View Source [SID1234614176]).

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HIGHLIGHTS
STRONG REVENUE GROWTH IN ALL BUSINESS AREAS FUELLED BY ONGOING EXPANSION AND STRENGTHENS POSITIVE DEVELOPMENT
Group revenues increased by 24% to € 164.7 m (Q1 2021: € 133.1 m); like-for-like base revenue growth (excluding fx effects) up 19%
Revenues from milestones, upfronts and licenses of € 4.5 m above last year (Q1 2021: € 4.4 m)
Strong progress in both segments: Total EVT Execute revenues up 27% to € 174.5 m (Q1 2021: € 136.9 m); EVT Innovate revenues also up 27% to € 35.9 m (Q1 2021: € 28.2 m)
Adjusted Group EBITDA of € 18.9 m (Q1 2021: € 21.1 m) primarily driven by capacity expansions at all sites, in particular the continued ramp-up of our J.POD Redmond (US) facility, an increase in unpartnered R&D (up 12%), partially offset by positive currency effects
Other non-operating result of € (69.2) m (Q1 2021: € 47.7 m) affected from a non-cash fair value adjustments of the equity participation in public listed Exscientia plc.

SETTING THE PACE WITH PRECISION MEDICINE PLATFORMS
New data-driven drug discovery collaboration with Eli Lilly and Company ("Lilly") in metabolic diseases
Drug discovery partnership with Boehringer Ingelheim in ophthalmology based on induced pluripotent stem cells ("iPSCs")
Launch of Evotec’s translational molecular patient database E.MPD, one of the largest and highest quality molecular databases globally
Further strong progress in neuroscience and oncology collaboration with Bristol Myers Squibb ("BMS")
Strong growth momentum in all areas e.g., new INDiGO agreements, CMC, screening and sample management alliances as well as several new integrated drug discovery & development alliances
Grant from BMBF to support clinical development of EVT075 in viral indications
Bayer initiated Phase II of bradykinin receptor B1 BAY 2395840 in diabetic neuropathic pain but also terminated further development of P2X3 antagonist eliapixant
Expansion of licensing agreement with JingXin for EVT201, submission of regulatory approval in China through JingXin (after period-end)
Successful expansion of the EVOequity portfolio with new equity stakes in several highly promising companies (e.g., Tubulis; after period-end)

CORPORATE
Dr Matthias Evers joins Evotec as Chief Business Officer (after period-end)

BUSINESS OUTLOOK FOR FULL-YEAR 2022 AND MID-TERM TARGETS 2025 CONFIRMED
Group revenues expected to be in a range of € 700 – 720 m (€ 690 – 710 m at constant exchange rates) (2021: € 618 m)
Adjusted Group EBITDA expected to be in the range of € 105 – 120 m (€ 95 – 110 m at constant exchange rates) (2021: € 107 m)
Unpartnered research and development expenses expected to be in a range of € 70 – 80 m (2021: € 58 m)
Mid-term goals target revenue growth to > € 1,000 m, adjusted EBITDA of ≥ € 300 m and unpartnered research and development expenses of > € 100 m by 2025
The forecast takes in account – as far as possible – the current global uncertainties related to the COVID-19 pandemic and the Russian invasion of Ukraine.

Webcast/Conference Call

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details
To join the audio webcast and to access the presentation slides you will find a link on our homepage www.evotec.com shortly before the event.
The on-demand version of the webcast will be available on our website: View Source

On May 11, 2022 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported financial results (IFRS, unaudited) for the first three months of 2022 (Press release, Epigenomics, MAY 11, 2022, View Source [SID1234614174]).

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Financial key figures

Revenues in the first quarter 2022 increased slightly from EUR 106 thousand to EUR 115 thousand compared to the prior-year period.
R&D costs increased from EUR 737 thousand in the first quarter 2021 to EUR 1,401 thousand in Q1 2022 to support the advancement of Epi proColon "Next-Gen". Additionally, short-time work at the Berlin site was terminated in mid-September 2021 and additional personnel were recruited in the U.S.A. for the "Next-Gen" development and study.
Selling and administrative expenses increased from EUR 1,601 thousand to EUR 2,015 thousand, mainly due to U.S. market studies.
EBITDA (before share-based payment expenses) amounted to EUR -2,574 thousand in the reporting period, compared with EUR -985 thousand in the same period of the previous year.
The net loss for the period was EUR -2,657 thousand (Q1 2021: EUR -1,201 thousand); the loss per share decreased from EUR 0.20 to EUR 0.17 compared to the same period of the previous year.
Cash consumption increased to EUR 3,408 thousand in the first quarter of 2022 (Q1 2021: EUR 2,386 thousand).
As of March 31, 2022, the Company had cash and cash equivalents of EUR 20,039 thousand (December 31, 2021: EUR 23,049 thousand).
Operational developments

During the 2022 conversion windows for the mandatory convertible bonds issued in January 2021 and September 2021, bonds were converted into 817,564 new shares (ISIN DE000A3H2184). Accordingly, the number of shares outstanding increased from 15,539,737 to 16,357,301 no-par value registered shares of the Company. The Company’s share capital increased accordingly to EUR 16,357,301.00.
The Company continues to make progress on the "Next-Gen" development and clinical trial. The Company is on-track to initiate the trial this summer and publish preliminary assay performance data this year.
"We are very pleased with our progress on Epi proColon "Next-Gen" and remain on-track to achieve our development and trial goals for this year", said Greg Hamilton, CEO of Epigenomics. "We are optimistic that the performance of "Next-Gen" will result in a significant market opportunity in the years to come."

Outlook 2022

Revenue

The Company confirms its outlook for fiscal year 2022 and continues to expect revenue within the range of EUR 0.3 million to EUR 0.8 million. If Medicare reimbursement is indeed achieved via legislation in 2022, the Company is likely to amend the revenue forecast.
EBITDA / cash consumption

For EBITDA (before share-based payment expenses), Epigenomics forecasts a range of EUR -15.0 million to EUR -17.0 million. This assumes that the Company initiates the Epi proColon "Next-Gen" trial in the summer of 2022. If this trial is delayed or enrollment is slower than anticipated then the forecast for the adjusted EBITDA is likely to improve. The anticipated spend for the clinical trial in 2022 will be aligned with the Company’s ability to raise funds for the remainder of the trial in 2023 and 2024.
Further information

The interim statement for the first three months 2022 (unaudited) can be found on Epigenomics’ website at: View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 4.00 pm (CET) / 10.00 am (EDT). The webcast can be accessed on the Company’s website View Source

Participants are asked to dial in 10 minutes prior to the start of the conference call and to register using the link above.

An audio replay of the conference call will be provided on the Epigenomics’ website subsequently.

On May 11, 2022 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported its financial results for the first quarter ended March 31, 2022 and provides a corporate update (Press release, BioLineRx, MAY 11, 2022, View Source [SID1234614171]).

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Significant events and achievements during the first quarter 2022 and subsequent period:

Progressed the New Drug Application (NDA) for Motixafortide in stem cell mobilization, remaining on track to submit mid-year;
Advanced critical pre-launch activities while maintaining full optionality with respect to Motixafortide commercialization plans in the U.S., if approved;
Commissioned a comprehensive third-party market assessment of the US stem cell mobilization market, which identified a commercial opportunity of ~$360 million annually in the U.S. alone;
Announced significantly positive and commercially relevant results from a pharmacoeconomic cost effectiveness study comparing Motixafortide + G-CSF versus G-CSF alone and indirectly comparing Motixafortide + G-CSF versus plerixafor + G-CSF:
– Versus plerixafor + G-CSF, the study found that the addition of Motixafortide to G-CSF is associated with a net cost savings of ~$30,000 per patient (not including the cost of Motixafortide).

– Versus G-CSF alone, the study found that the addition of Motixafortide to G-CSF is associated with a net cost savings of ~$19,000 per patient (not including the cost of Motixafortide).

Completed recruitment of part 2 of ongoing Phase 1/2a trial of AGI-134 in solid tumors;
Ended the first quarter on solid financial footing, with cash and cash equivalents of $50.6 million, sufficient to fund operations, as currently planned, into the first half of 2024.
"During the first quarter and subsequent period, we continued to prepare our New Drug Application for Motixafortide in stem cell mobilization, and we remain on track for submission to the FDA mid-year, consistent with our prior guidance," stated Philip Serlin, Chief Executive Officer of BioLineRx. "In parallel, we are advancing a range of critical pre-launch activities, should Motixafortide be approved, while maintaining full optionality with respect to our commercialization plans, in light of the highly concentrated end market in the U.S., in which 80 transplant centers conduct the vast majority of stem cell transplant procedures.

"The third-party commercial market assessment that we recently commissioned estimates the size of the stem cell mobilization market to be $360 million annually in the U.S. alone and growing. In this respect, the overwhelmingly positive results from our GENESIS Phase 3 study, together with the very compelling cost savings identified through our pharmacoeconomic cost effectiveness studies, give us optimism that Motixafortide, if approved, can quickly become a core component of a new mobilization paradigm in multiple myeloma patients, and in potential other indications as well.

"With over $50 million in cash, we believe we are well financed to extract maximum value from Motixafortide in stem cell mobilization while at the same time advancing our other pipeline programs, allowing us to achieve notable corporate and clinical milestones into the first half of 2024," concluded Mr. Serlin.

Upcoming Expected Milestones:

Submission of NDA to FDA for Motixafortide as novel mobilization agent for multiple myeloma patients undergoing autologous stem cell transplantation in mid-2022;
Initial results from Part 2 of Phase 1/2a trial of AGI-134 in solid tumors in H2 2022;
Initiate Phase 2 study of AGI-134 in 2023;
Potential FDA approval of Motixafortide in 2023;
Potential US launch of Motixafortide in SCM in 2023.
Financial Results for the Quarter Ended March 31, 2022:

Research and development expenses for the quarter ended March 31, 2022 were $4.4 million, an increase of $0.1 million, or 3.7%, compared to $4.3 million for the quarter ended March 31, 2021. The increase resulted primarily from an increase in expenses associated with the AGI-134 study, offset by lower expenses associated with the completed Motixafortide GENESIS and COMBAT clinical trials.

Sales and marketing expenses for the quarter ended March 31, 2022 were $0.7 million, an increase of $0.5 million, or 313% compared to $0.2 million for the quarter ended March 31, 2021. The increase resulted primarily from an increase in market research and consultancy services, as well as initiation of pre-launch activities related to Motixafortide.

General and administrative expenses for the quarter ended March 31, 2022 were $1.0 million, similar to the comparable period in 2021.

The Company’s operating loss for the quarter ended March 31, 2022 amounted to $6.1 million, compared to an operating loss of $5.4 million for the quarter ended March 31, 2021.

Non-operating income amounted to $1.3 million for the quarter ended March 31, 2022, compared to non-operating expenses of $4.6 million for the quarter ended March 31, 2021. Non-operating income (expenses) for both periods primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet.

Net financial expenses amounted to $0.1 million for the quarter ended March 31, 2022, compared to net financial expenses of $0.2 million for the quarter ended March 31, 2021. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.

The Company’s net loss for the quarter ended March 31, 2022 amounted to $4.9 million, compared with a net loss of $10.2 million for the quarter ended March 31, 2021.

The Company held $50.6 million in cash, cash equivalents and short-term bank deposits as of March 31, 2022, compared with $57.1 million as of December 31, 2021.

Net cash used in operating activities was $5.6 million for the quarter ended March 31, 2022, compared with net cash used in operating activities of $6.2 million for the quarter ended March 31, 2021. The $0.6 million decrease in net cash used in operating activities between the two periods was primarily the result of changes in operating asset and liability items in the two periods, i.e., a smaller increase in prepaid expenses and other receivables in 2022 versus 2021, as well as increase in accounts payable and accruals in 2022, versus a decrease in the 2021 period.

Net cash provided by investing activities was $5.0 million for the quarter ended March 31, 2022, compared to net cash used in investing activities of $36.3 million for the quarter ended March 31, 2021. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.

Net cash used in financing activities was $1.0 million for the quarter ended March 31, 2022, compared to net cash provided by financing activities of $41.9 million for the quarter ended March 31, 2021. The cash flows in 2022 primarily reflect repayments of the loan from Kreos Capital. The cash flows in 2021 primarily reflect the underwritten public offering of ADSs in January 2021, warrant exercises, and net proceeds from an ATM facility, offset by repayments of the loan from Kreos Capital.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, Wednesday, May 11 at 10:00 a.m. EDT. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0644 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until May 13, 2022; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.