☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
PDS Biotechnology Corporation
|
||
(Exact name of registrant as specified in its charter)
|
Delaware
|
26-4231384
|
|
(State or other jurisdiction of incorporation or organization)
|
(IRS Employer Identification No.)
|
303A College Road East, Princeton, NJ 08540
|
||
(Address of principal executive offices)
|
(800) 208-3343
|
||
(Registrant’s telephone number)
|
(Former name, former address and former fiscal year, if changed since last report)
|
Title of each class
|
Trading symbol(s)
|
Name of each exchange on which registered
|
||
Common Stock, par value $0.00033 per share
|
PDSB
|
The Nasdaq Stock Market LLC
|
Large accelerated filer ☐
|
Accelerated filer ☐
|
Non-accelerated filer ☒
|
Smaller Reporting Company ☒
|
Emerging growth company ☐
|
Page
|
|||
Part I — Financial Information
|
|||
Item 1.
|
|||
3
|
|||
4
|
|||
5
|
|||
6
|
|||
7
|
|||
Item 2.
|
17
|
||
Item 3.
|
30
|
||
Item 4.
|
30
|
||
31
|
|||
Item 1.
|
31
|
||
Item 1A.
|
31
|
||
Item 2.
|
31
|
||
Item 3.
|
31
|
||
Item 4.
|
31
|
||
Item 5.
|
31
|
||
Item 6.
|
31
|
||
32
|
|||
33
|
PART 1.
|
FINANCIAL INFORMATION
|
|
March 31, 2024
|
December 31, 2023
|
||||||
ASSETS
|
(unaudited)
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
66,634,417
|
$
|
56,560,517
|
||||
Prepaid expenses and other assets
|
2,051,348
|
2,494,558
|
||||||
Total current assets
|
68,685,765
|
59,055,075
|
||||||
Property and equipment, net
|
129,398
|
134,132
|
||||||
Financing lease right-to-use assets
|
191,203 | 200,873 | ||||||
Total assets
|
$
|
69,006,366
|
$
|
59,390,080
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
6,000,831
|
$
|
6,982,824
|
||||
Accrued expenses
|
1,714,111
|
2,424,692
|
||||||
Note payable - short term
|
7,291,667 | 4,166,667 | ||||||
Financing lease obligation-short term
|
57,081
|
55,794
|
||||||
Total current liabilities
|
15,063,690
|
13,629,977
|
||||||
Noncurrent liabilities:
|
||||||||
Note payable, net of debt discount
|
16,651,420 | 19,506,183 | ||||||
Financing lease obligation-long term
|
108,211 | 122,973 | ||||||
Total liabilities:
|
$
|
31,823,321
|
$
|
33,259,133
|
||||
STOCKHOLDERS’ EQUITY
|
||||||||
Common stock, $0.00033
par value, 75,000,000 shares authorized at March 31, 2024 and December 31, 2023, 36,679,275 shares and 33,094,521 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively
|
12,104
|
10,921
|
||||||
Additional paid-in capital
|
192,275,033
|
170,620,641
|
||||||
Accumulated deficit
|
(155,104,092
|
)
|
(144,500,615
|
)
|
||||
Total stockholders’ equity
|
37,183,045
|
26,130,947
|
||||||
Total liabilities and stockholders’ equity
|
$
|
69,006,366
|
$
|
59,390,080
|
Three Months Ended March 31,
|
||||||||
2024
|
2023
|
|||||||
Operating expenses:
|
||||||||
Research and development expenses
|
$
|
6,704,164
|
$
|
5,843,686
|
||||
General and administrative expenses
|
3,393,463 |
3,578,728
|
||||||
Total operating expenses
|
10,097,627
|
9,422,414 | ||||||
Loss from operations
|
(10,097,627 | ) | (9,422,414 | ) | ||||
Interest income (expense), net
|
||||||||
Interest income
|
668,895 | 729,341 | ||||||
Interest expense
|
(1,174,745 | ) | (966,845 | ) | ||||
Interest income (expense), net
|
(505,850 | ) |
(237,504
|
)
|
||||
Net loss and comprehensive loss
|
|
(10,603,477
|
)
|
|
(9,659,918 | ) | ||
Per share information:
|
||||||||
Net loss per share, basic and diluted
|
$ | (0.30 | ) | $ | (0.32 | ) | ||
Weighted average common shares outstanding basic and diluted
|
34,815,870 | 30,428,053 |
Common Stock
|
|
|||||||||||||||||||
Shares
Issued
|
Amount
|
Additional
Paid-in
Capital
|
Accumulated
Deficit
|
Total Equity
|
||||||||||||||||
January 1, 2023
|
30,170,317
|
$
|
9,956
|
$
|
145,550,491
|
$
|
(101,558,417
|
)
|
$
|
44,002,030
|
||||||||||
Stock-based compensation expense
|
–
|
–
|
2,080,319
|
–
|
2,080,319
|
|||||||||||||||
Issuances of common stock from the Sales Agreement, net
|
553,293
|
183
|
4,588,339
|
–
|
4,588,522
|
|||||||||||||||
Net loss
|
–
|
–
|
–
|
(9,659,918
|
)
|
(9,659,918
|
)
|
|||||||||||||
Balance - March 31, 2023
|
30,723,610
|
$
|
10,139
|
$
|
152,219,149
|
$
|
(111,218,335
|
)
|
$
|
41,010,953
|
Common Stock
|
|
|||||||||||||||||||
Shares
Issued
|
Amount
|
Additional
Paid-in
Capital
|
Accumulated
Deficit
|
Total Equity
|
||||||||||||||||
January 1, 2024
|
33,094,521
|
$
|
10,921
|
$
|
170,620,641
|
$
|
(144,500,615
|
)
|
$
|
26,130,947
|
||||||||||
Stock-based compensation expense
|
–
|
–
|
1,630,011
|
–
|
1,630,011
|
|||||||||||||||
Issuances of common stock from the Sales Agreement, net
|
3,428,681 | 1,131 | 19,493,342 | – | 19,494,473 | |||||||||||||||
Issuances of common stock, from exercise of stock options | 156,073 | 52 | 531,039 | – | 531,091 | |||||||||||||||
Net loss
|
–
|
–
|
–
|
(10,603,477
|
)
|
(10,603,477
|
)
|
|||||||||||||
Balance - March 31, 2024
|
36,679,275
|
$
|
12,104
|
$
|
192,275,033
|
$
|
(155,104,092
|
)
|
$
|
37,183,045
|
Three Months Ended March 31,
|
||||||||
2024
|
2023
|
|||||||
Cash flows from operating activities:
|
||||||||
Net loss
|
$
|
(10,603,477
|
)
|
$
|
(9,659,918
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Stock-based compensation expense
|
1,630,011
|
2,080,319
|
||||||
Amortization of debt discount
|
270,236 | 121,997 | ||||||
Depreciation expense
|
4,735
|
3,155
|
||||||
Operating lease expense
|
–
|
60,257
|
||||||
Finance lease depreciation expense
|
9,670 | 10,957 | ||||||
Changes in assets and liabilities:
|
||||||||
Prepaid expenses and other assets
|
443,210
|
(113,758
|
)
|
|||||
Accounts payable
|
(981,993
|
)
|
852,774
|
|||||
Accrued expenses
|
(710,581
|
)
|
(6,455,317
|
)
|
||||
Operating lease liabilities
|
–
|
(89,102
|
)
|
|||||
Net cash used in operating activities
|
(9,938,189
|
)
|
(13,188,636
|
)
|
||||
Cash flows from financing activities: | ||||||||
Proceeds from exercise of stock options
|
531,091 | – | ||||||
Payments of finance lease obligations
|
(13,475
|
)
|
(20,667 | ) | ||||
Proceeds from issuance of common stock, net of issuance costs
|
19,494,473 | 4,588,522 | ||||||
Net cash provided by financing activities
|
20,012,089 |
4,567,855
|
||||||
Net increase in cash and cash equivalents
|
10,073,900
|
(8,620,781
|
)
|
|||||
Cash and cash equivalents at beginning of period
|
56,560,517
|
73,820,160
|
||||||
Cash and cash equivalents at the end of period | $ | 66,634,417 | $ | 65,199,379 | ||||
Supplemental information of cash and non-cash transactions:
|
||||||||
Cash paid for interest
|
$
|
1,174,745
|
$
|
966,845
|
(A) |
Unaudited interim financial statements:
|
(B) |
Use of estimates:
|
(C) |
Significant risks and uncertainties:
|
(D) |
Cash equivalents and concentration of cash balance:
|
(E) |
Research and development:
|
(F) |
Patent costs:
|
(G) |
Stock-based compensation:
|
(H) |
Net loss per common share:
|
|
As of March 31,
|
|||||||
2024
|
2023
|
|||||||
Stock options to purchase Common Stock
|
5,314,661
|
5,295,911
|
||||||
Warrants to purchase Common Stock
|
466,112
|
506,229
|
||||||
Total
|
5,780,773
|
5,802,140
|
(I) |
Income taxes:
|
(J)
|
Fair value of financial instruments:
|
|
● |
Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the
measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities.
|
|
● |
Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g.,
quoted prices of similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models
or other valuation methodologies.
|
|
● |
Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using
pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable.
|
(K)
|
Leases:
|
(L)
|
New accounting standards:
|
Fair Value Measurements at Reporting Date Using
|
||||||||||||||||
Total
|
Quoted Prices in
Active Markets
(Level 1)
|
Quoted Prices in
Inactive Markets
(Level 2)
|
Significant
Unobservable Inputs
(Level 3)
|
|||||||||||||
As of March 31, 2024: (unaudited)
|
||||||||||||||||
Cash and cash equivalents
|
$
|
66,634,417
|
$
|
66,634,417
|
$
|
–
|
$
|
–
|
||||||||
As of December 31, 2023
|
||||||||||||||||
Cash and cash equivalents
|
$
|
56,560,517
|
$
|
56,560,517
|
$
|
–
|
$
|
–
|
As of March 31,
|
||||||||
2024
|
2023
|
|||||||
Cash paid for operating lease liabilities
|
$
|
–
|
$
|
89,102
|
As of March 31,
|
||||||||
2024
|
2023
|
|||||||
Cash paid for finance lease liabilities
|
$
|
17,463
|
$
|
20,667
|
Year ended December 31,
|
||||
2024
|
$
|
52,387
|
||
2025
|
|
69,850
|
||
2026
|
|
40,108
|
||
2027
|
|
26,721
|
||
2028 and after
|
|
1
|
||
Total future minimum lease payments
|
189,067
|
|||
Less imputed interest
|
(23,775
|
)
|
||
Remaining lease liability
|
$
|
165,292
|
As of
March 31, 2024
|
As of
December 31, 2023
|
|||||||
Accrued research and development
|
$
|
457,229
|
$
|
-
|
||||
Accrued professional fees
|
531,294
|
827,863
|
||||||
Accrued compensation
|
418,449
|
1,289,690
|
||||||
Accrued interest on debt
|
306,771 | 306,771 | ||||||
Accrued rent | 368 | 368 | ||||||
Total
|
$
|
1,714,111
|
$
|
2,424,692
|
Three Months Ended March 31, |
||||||||
2024
|
2023
|
|||||||
(unaudited) |
||||||||
|
||||||||
Research and development
|
$ |
551,918
|
$ |
800,764
|
||||
General and administrative
|
1,078,093
|
1,279,555
|
||||||
Total
|
$ |
1,630,011
|
$ |
2,080,319
|
Three Months Ended March 31,
|
||||||||
2024
|
2023
|
|||||||
Weighted Average
|
Weighted Average
|
|||||||
(unaudited)
|
||||||||
Volatility
|
145.41
|
%
|
142.02
|
%
|
||||
Risk-Free Interest Rate
|
3.98
|
%
|
4.06
|
%
|
||||
Expected Term in Years
|
6.08
|
6.08
|
||||||
Dividend Rate | – | – | ||||||
Fair Value of Option on Grant Date
|
$
|
5.22
|
$
|
10.79
|
Number
of Shares
|
Weighted
Average
Exercise Price
|
Weighted Average
Remaining
Contractual
Life in Years
|
Aggregate
Intrinsic Value
|
|||||||||||||
Options outstanding at December 31, 2023
|
5,029,345
|
$
|
6.43
|
7.42
|
$
|
4,395,227
|
||||||||||
Granted
|
938,648
|
5.58
|
9.90 | – | ||||||||||||
Exercised
|
(156,073
|
)
|
3.40
|
|||||||||||||
Forfeited and expired
|
(497,259
|
)
|
8.64
|
|||||||||||||
Options outstanding at March 31, 2024
|
5,314,661
|
$
|
6.16
|
7.60
|
$
|
2,327,199
|
||||||||||
Vested and expected to vest at March 31, 2024
|
5,314,661
|
$
|
6.16
|
7.60
|
$
|
2,327,199
|
||||||||||
Exercisable at March 31, 2024
|
2,858,485
|
$
|
5.80
|
6.42
|
$
|
1,971,346
|
ITEM 2.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
●
|
the Company’s ability to protect its intellectual property rights;
|
● |
the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings;
|
● |
the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its clinical candidates, and the risks that raising such additional capital may
restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or clinical candidates;
|
● |
the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s
successful implementation of such business plan;
|
● |
the timing for the Company or its partners to initiate the planned clinical trials for its Versamune® products, including PDS0101, PDS0103, and others, alone or in
combination with PDS01ADC, as well as Infectimune® based clinical candidates and the future success of such trials;
|
● |
the successful implementation of the Company’s research and development programs and collaborations, including any collaboration trials concerning the Company’s Versamune®, PDS01ADC and Infectimune® based clinical
candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s clinical candidates;
|
● |
the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current clinical candidates, including statements regarding the timing of initiation, pace of
enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data
reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials;
|
● |
expectations for the clinical and preclinical development, manufacturing, regulatory approval, and commercialization of the Company’s clinical candidates;
|
● |
any Company statements about its understanding of clinical candidates’ mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration
trials; the acceptance by the market of the Company’s clinical candidates, if approved;
|
● |
the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s clinical candidates; and
|
● |
other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising
from or related to those listed under Part II, Item 1A. Risk Factors.
|
●
|
Confirmed and unconfirmed response rates thus far (tumor shrinkage greater than 30%) seen in 7/17 (41.2%) patients in comparison to the published results of approximately 19% for approved ICIs, used as monotherapy for recurrent or
metastatic head and neck cancer, with 2 of the 7 having complete responses (CR)
|
● |
Stable disease (SD) was reported in 6/17 (35.3%) patients, with 4 of the 6 (67%) experiencing tumor shrinkage of less than 30%
|
● |
Clinical efficacy (ORR + SD) was seen in 13/17 (76.5%) patients
|
● |
Progressive/ongoing disease was reported in 4/17 (23.5%) patients
|
● |
Patients had received a median of 4/5 doses of PDS0101 (range 1-5) and 9/35 doses of Keytruda® (range 1-18)
|
● |
There were no treatment-related adverse events greater than or equal to Grade 3 (N=19)
|
● |
No patients required dose interruption or reduction on the combination treatment
|
● |
No patients discontinued the combination treatment
|
● |
At 9 months of follow up (median not yet achieved):
|
● |
Progression free survival (PFS) rate was 55.2%
|
● |
Overall survival (OS) rate was 87.2%
|
● |
no control or comparative studies have been conducted between ICIs and PDS0101
|
●
|
Estimated 12-month overall survival rate was 87.1%. Published results are 36-50% with approved ICIs used alone.
|
● |
Median progression-free survival was 10.4 months (95% CI 4.2, 15.3). Published results are median PFS of 2-3 months for approved ICIs when used as monotherapy in patients with similar PD-L1 levels.
|
● |
A disease control rate (disease stabilization or tumor shrinkage) of 70.6% (24/34)
|
● |
Confirmed and unconfirmed objective response rate is 41.2% (14/34 patients), which is identical to the preliminary response rate data PDS Biotech previously reported at ASCO 2022 (7/17 patients). To date these responses have been
confirmed in nine of the 34 patients (26.5%), including one complete response.
|
● |
15/34 patients (44.1%) had stable disease.
|
● |
9/34 patients (26.5%) had progressive disease.
|
● |
4/48 (8.3%) of patients had a Grade 3 treatment-related adverse event (TRAE). No Grade 4 or higher TRAEs were observed.
|
●
|
24-month overall survival (OS) rate is 74%; published 24-month survival rate of less than 30% for approved ICI.
|
● |
12-month OS rate is 80%; published results of 30-50% with approved ICIs.
|
● |
Tumor shrinkage seen in 60% (31/52) of patients.
|
● |
Confirmed overall response rate ORR is 27% (14/52) to date.
|
● |
Median progression-free survival (PFS) is 8.1 months to date; published results of 2-3 months PFS with approved ICIs.
|
● |
13% (8/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 0% (0/62) experienced Grade 4 or 5 TRAE; published results report 13-17% Grade 3-5 TRAE with approved ICI monotherapy.
|
● |
60% (33/55) of patients have CPS score of 1-19 (who generally have a weaker response to Keytruda®), and 40% (22/55) have CPS score >20 (who generally have a higher response to Keytruda®).
|
● |
The 12-month OS rate is 56%. The published median 12-month OS rate is 17% with no salvage chemotherapy following tumor progression on ICI (ICI Resistant).
|
● |
0% (0/21) confirmed ORR suggests that PDS0101’s impact on survival does not appear to be dependent on tumor shrinkage.
|
● |
4% (1/25) of patients experienced Grade 3 TRAE and 0% (0/21) patients experienced Grade 4 and 5 TRAE.
|
● |
Median overall survival of 30 months; published results for ICIs are 7-18 months.
|
● |
Confirmed overall response rate ORR is 34% (18/53) to date; published results for comparable patients receiving treatment with ICIs are less than 20%.
|
● |
Confirmed complete responses, partial responses and stable disease according to RECIST v1.1 were seen in 75.5% of patients.
|
● |
Median progression-free survival (PFS) is 6.3 months to date; published results of 2-3 months PFS with approved ICIs.
|
● |
The combination of PDS0101 and Keytruda® appeared to be well tolerated with 11% (7/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 2% (1/62) experienced Grade 4 or 5 TRAE; published results report 13-17%
Grade 3-5 TRAE with approved ICI monotherapy.
|
● |
60% (32/53) of patients have CPS score of 1-19 (who generally have a weaker response to Keytruda®), and 40% (21/53) have CPS score >20 (who generally have a higher response to Keytruda®).
|
● |
Objective response (OR = >30% tumor reduction) was seen in 88% (7/8) of patients with ICI naive disease; 4/7 (57%) patients’ responses are ongoing (median 17 months).
|
● |
With ICI resistant patients: PDS01ADC dosing appears to affect response rates, with 5/8 (63%) patients receiving PDS01ADC at 16.8 mcg/kg achieving an OR compared to 1/14 (7%) patients who received PDS01ADC at 8
mcg/kg achieving an OR; 4/6 (67%) patients’ responses are ongoing (median 12 months).
|
● |
Tumor reduction was seen in 45% (10/22) of patients with ICI resistant disease, including patients receiving high or low dose PDS01ADC.
|
● |
In ICI resistant patients treated with high or low dose PDS01ADC, survival outcomes were similar (p=0.96 by Kaplan Meier analysis). At a median of 12 months of follow up 17/22 (77%) of patients were alive.
|
● |
In ICI naïve patients 6/8 (75%) were alive at median 17 months of follow up.
|
● |
Similar OR and survival were seen across all types of HPV16-positive cancers.
|
● |
Preliminary safety data: 13/30 (43%) of patients experienced Grade 3 treatment-related adverse events (AEs), and 2/30 patients (7%) experienced Grade 4 AEs. There were no grade 5 treatment-related AEs.
|
● |
Survival data: 66% (19/29) of HPV16-positive ICI resistant patients in the cohort were alive at a median follow up of 16 months.
|
● |
Safety profile: 48% (24/50) patients experienced Grade 3 treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 AEs. There were no Grade 5 treatment-related AEs.
|
● |
HPV16-positive ICI naïve patients: 75% (6/8) were alive at a median follow up of 25 months and 38% (3/8) of responders had a complete response.
|
● |
Median OS was 21 months in 29 checkpoint inhibitor resistant patients who received the triple combination. The reported historical median OS in patients with ICI resistant disease is 3-4 months seen with
checkpoint inhibitors and best reported median survival to date with systemic therapy of 8.2 months in ICI resistant head and neck cancer.
|
● |
In ICI naïve subjects, 75% remain alive at a median follow-up of 27 months. As a result, median OS had not yet been reached. Historically median OS for similar patients with platinum experienced ICI naïve disease
is 7-11 months.
|
● |
Objective response rate (ORR) in ICI resistant patients who received the optimal dose of the triple combination is 63% (5/8). In current approaches ORR is reported to be less than 10%.
|
● |
ORR in ICI naïve patients with the triple combination is 88%. In current approaches ORR is reported to be less than 25% with FDA-approved ICIs in HPV-positive cancers.
|
● |
Safety data had not changed since October’s update. 48% (24/50) of patients experienced Grade 3 (moderate) treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 (severe) AEs, compared
with approximately 70% of patients receiving the combination of ICIs and chemotherapy reporting Grade 3 and higher treatment-related AEs..
|
● |
75% of immune checkpoint inhibitor (ICI) naïve patients remain alive at 36 months; published median overall survival (OS) in similar patients is 7-11 months
|
● |
12-month survival rate in (ICI) resistant patients of 72%
|
● |
Median OS in ICI resistant HPV-positive patients is approximately 20 months; published median OS is 3.4 months
|
● |
9 of the 17 patients had completed a Day 170 post-treatment Positron Emission Tomography, Computed Tomography (PET CT) scan to assess the status of the cancer. This included 78% (7/9) of treated patients with
advanced cervical cancer (FIGO stage III or IV).
|
● |
100% (9/9) of patients treated with the combination of PDS0101 and CRT had an objective response.
|
● |
89% (8/9) of patients treated with the combination of PDS0101 and CRT demonstrated a complete response (CR) on Day 170 by PET CT. One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs of
residual disease. One patient who had a CR died from an event unrelated to either their underlying disease or treatment.
|
● |
1-year disease-free survival and 1-year overall survival of 89% (8/9) in patients treated with the combination of PDS0101 and CRT.
|
● |
As previously reported, data confirm PDS0101 treatment activates HPV16-specific CD8 T cells. This increase was not seen in patients who did not receive PDS0101. The increase in HPV16-specific T cells generated by
the treatment is positively correlated with tumor cell death, suggesting cytotoxic CD8 T cells are important mediators of antigen-specific immunity.
|
● |
The data affirms that PDS0101 activates Type 1 interferon pathway in humans, mimicking the mechanism previously demonstrated in preclinical studies in animal models.
|
● |
Toxicity of PDS0101 remains limited to low-grade local injection site reactions.
|
● |
Earlier and greater proportion of ctDNA clearance with PDS0101 plus chemoradiation (CRT) vs. SOC CRT alone (81.3% clearance after 3 weeks vs. 30.3% with SOC (p=0.0018), and 91.7% of clearance at 5 weeks vs. 53.1% with SOC (p=0.0179).
|
● |
Baseline ctDNA levels correlated with the International Federation of Gynecology and Obstetrics (FIGO) stage and lymph node involvement; 100% of patients treated with PDS0101 had cancer that had spread to the lymph nodes.
|
● |
Phase II Study Evaluating ICI Naïve and Resistant Patients with HPV-positive malignancies treated with PDS01ADC, PDS0101 and bintrafusp alfa.
|
● |
A Phase II Study Evaluating T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination with the Immunocytokine PDS01ADC in Localized High and Intermediate Risk Prostate Cancer Treated with Androgen Deprivation
Therapy
|
● |
A Phase I/II Study of PDS01ADC in Combination with Docetaxel in Adults with Metastatic Castration Sensitive and Castration Resistant Prostate Cancer
|
● |
Phase I/II of PDS01ADC going forward as a Monotherapy in Advanced Kaposi Sarcoma
|
● |
Phase I/II of PDS01ADC in Combination of with a Histone Deacetylase (HDAC) Inhibitor in ICI resistant MUC1-positive colon and bladder cancers among others
|
● |
Decrease in PSA levels was seen in all patients at all three tested doses of PDS01ADC and 61% of patients had at least a 60% decrease in PSA levels.
|
● |
All doses of the combination were well-tolerated with one patient experiencing Grade 4 neutropenia.
|
● |
Administration of the combination was associated with decreases in T reg cells and increases in activated natural killer (NK) cells, memory CD8 T cells, proliferating CD4 and CD8 T cells and cytokines INF-γ and Interleukin 10 (IL-10).
|
● |
The changes in immune responses with the combination were independent of the PDS01ADC dose.
|
● |
the timing and costs of our planned clinical trials;
|
● |
the timing and costs of our planned preclinical studies of our Versamune® platform;
|
● |
the outcome, timing and costs of seeking regulatory approvals;
|
● |
the terms and timing of any future collaborations, licensing, consulting or other arrangements that we may enter into;
|
● |
the amount and timing of any payments we may be required to make in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any patents or patent applications or other
intellectual property rights; and
|
● |
the extent to which we license or acquire other products and technologies.
|
|
Three Months Ended
March 31,
|
Increase
|
||||||||||||||
|
2024
|
2023
|
$ Amount
|
%
|
||||||||||||
|
(in thousands)
|
|||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
6,704
|
$
|
5,844
|
$
|
860
|
15
|
%
|
||||||||
General and administrative expenses
|
3,393
|
3,579
|
(186
|
)
|
(5
|
)%
|
||||||||||
Total operating expenses
|
10,097
|
9,423
|
674
|
7
|
%
|
|||||||||||
Loss from operations
|
(10,097
|
)
|
(9,423
|
)
|
(674
|
)
|
7
|
%
|
||||||||
Interest income (expense), net
|
(506
|
)
|
(237
|
)
|
(269
|
)
|
114
|
%
|
||||||||
Net loss and comprehensive loss
|
$
|
(10,603
|
)
|
$
|
(9,660
|
)
|
$
|
(943
|
)
|
10
|
%
|
|
Three Months Ended March 31,
|
|||||||
|
2024
|
2023
|
||||||
Net cash used in operating activities
|
$
|
(9,938
|
)
|
$
|
(13,189
|
)
|
||
Net cash provided by financing activities
|
20,012
|
4,568
|
||||||
Net increase (decrease) in cash and cash equivalents
|
$
|
10,074
|
$
|
(8,621
|
)
|
●
|
the initiation, progress, timing, costs and results of our planned clinical trials;
|
● |
the effects of health epidemics, pandemics, or outbreaks of infectious diseases, on our business operations, financial condition, results of operations and cash flows;
|
● |
the outcome, timing and cost of meeting regulatory requirements established by the U.S. Food and Drug Administration, or FDA, the European Medicines Agency, or EMA, and other comparable foreign regulatory
authorities;
|
● |
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
|
● |
the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against us now or in the future;
|
● |
the effect of competing technological and market developments;
|
● |
the cost of establishing sales, marketing and distribution capabilities in regions where we choose to commercialize our products on our own; and
|
● |
the initiation, progress, timing and results of our commercialization of our clinical candidates, if approved, for commercial sale.
|
ITEM 4: |
CONTROLS AND PROCEDURES
|
ITEM 1. |
LEGAL PROCEEDINGS
|
ITEM 1A. |
RISK FACTORS
|
ITEM 2. |
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
ITEM 3. |
DEFAULTS UPON SENIOR SECURITIES
|
ITEM 4. |
MINE SAFETY DISCLOSURES
|
ITEM 5. |
OTHER INFORMATION
|
ITEM 6. |
EXHIBITS
|
Exhibit
Number
|
Exhibit Description
|
|
10.1+
|
Executive Employment Agreement by and between Kirk V. Shephard, M.D. and PDS Biotechnology Corporation, effective as of January 22, 2024 (incorporated by reference to Exhibit 10.27 to the Registrant’s
Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 28, 2024).
|
|
10.2+
|
PDS Biotechnology Corporation 2019 Inducement Plan, as amended (filed as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on January 22, 2024, and incorporated by reference herein).
|
|
10.3*+
|
Executive Employment Agreement by and between Stephan F. Toutain and PDS Biotechnology Corporation, effective as of May 1, 2024.
|
|
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
||
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
||
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
|
||
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
|
||
101.INS*
|
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
|
|
101.SCH*
|
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents.
|
|
101.CAL*
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.DEF*
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
101.LAB*
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
101.PRE*
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
104
|
Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibits 101).
|
PDS Biotechnology Corporation
|
||
May 15, 2024
|
By:
|
/s/ Frank Bedu-Addo
|
Frank Bedu-Addo, Ph.D.
|
||
President and Chief Executive Officer
|
||
(Principal Executive Officer)
|
||
May 15, 2024
|
By:
|
/s/ Lars Boesgaard
|
Lars Boesgaard
|
||
Chief Financial Officer
|
||
(Principal Financial and Accounting Officer)
|
1. |
EMPLOYMENT BY THE COMPANY.
|
2. |
COMPENSATION.
|
3. |
PROPRIETARY INFORMATION, INVENTIONS, NON-COMPETITION AND
NON-SOLICITATION OBLIGATIONS.
|
PDS BIOTECHNOLOGY CORPORATION
|
|||
|
By:
|
|
|
Name: |
|
||
Title: |
|
||
EXECUTIVE: | |||
By: |
|
||
Name: |
Stephan F. Toutain, MS, MBA
|
Name:
|
Stephan F. Toutain, MS, MBA (“Executive”)
|
Address:
|
131Garfield Road, West Hartford, CT 06107
|
Telephone:
|
(860) 951-1925
|
Employment Start Date:
|
May 1, 2024
|
Employer: |
PDS Biotechnology Corporation, a Delaware corporation, and any of its affiliates, together with any of their respective successors or assigns (collectively, the “Company”).
|
|
1. |
Company Confidential Information. All Confidential Information is the sole
property of the Company or its designee. I hereby assign to the Company all rights, title, and interest I may have or acquire in the Confidential Information. At all times, both during and after my Employment, I agree to hold in the strictest
confidence, not to use (except for the benefit of the Company) and not to disclose to any person or entity (directly or indirectly), except as may be necessary in the ordinary course of performing my duties as an employee of the Company or as
expressly authorized by this Agreement, any Confidential Information that I obtain or create during my Employment, unless the Company grants me written authorization to do otherwise.
|
|
• |
information belonging to others who have entrusted such information to the Company, as further described in Section 3 below;
|
|
• |
information that would not have been known to competitors of the Company or the public generally if I had not breached my obligations of confidentiality under this
Agreement;
|
|
• |
information concerning research, inventions, discoveries, developments, techniques, processes, formulae, technology, designs, drawings, engineering, specifications,
algorithms, finances, sales or profit figures, financial plans, customer lists, customers, prospective customers, potential investors, business plans, contracts, markets, investing plans, product plans, marketing, distribution or sales methods
or systems, products, services, production plans, system implementation plans, business concepts, supplier or vendor information, business procedures or business operations related thereto;
|
|
• |
all computer software (in source, object or other code forms and including all programs, modules, routines, interfaces and controls), data, databases, Internet designs
and strategies, files and any documentation protocols and/or specifications related to the foregoing;
|
|
• |
all know-how and/or trade secrets;
|
|
• |
all unpublished copyrightable material;
|
|
• |
any use, model, variation, application, reduction to practice, discussion and any other communication or information in, regarding or relating to, or usable in or with
any of the goods or services made, used or sold by the Company; and
|
|
• |
all reproductions and copies of such things.
|
|
2. |
Third Party Information Held by Executive. I recognize that I may have access
to confidential or proprietary information of former employers or other persons or entities with whom I have an agreement or duty to keep such information confidential. I will not use any such information in my Employment, I will not disclose
any such information to the Company or any of its directors, officers, agents or other employees, or induce any of them to use any such information, and I will not bring onto the premises of the Company any such information in any form, unless
such person or entity has granted me written authorization to do so. I further warrant that my performance of all the terms of this Agreement and my Employment does not and will not breach any agreement to keep in confidence proprietary
information, knowledge or data acquired by me prior to my employment with Company.
|
|
3. |
Third Party Information Held by the Company. I recognize that the Company has
received, and in the future shall receive, from other persons or entities information that is confidential or proprietary to such person or entity; and, therefore, such persons or entities require the Company to maintain the confidentiality of
such information and to use it only for certain limited purposes. Consistent with the Company’s agreement with such persons or entities, I agree to treat such information as Confidential Information pursuant to this Agreement.
|
|
4. |
Company Property; Return. I will not remove (either physically or
electronically) any property belonging to the Company from the Company’s premises, except as required in the ordinary course of my Employment, unless the Company grants me written authorization to do so. Promptly upon the termination of my
Employment, and earlier if the Company so requests at any time, I shall deliver to the Company (and shall not keep copies in my possession or deliver to anyone else) all of the following items:
|
|
• |
Documents, communications (including emails) and other materials containing or comprising Confidential Information, including in particular, but not limited to, all
software, records, data, notes, reports, proposals, lists, correspondence, specifications, drawings, blueprints, sketches and laboratory notebooks, whether hard copies or soft copies (electronic or digital, including as stored on any personal
storage device or email or cloud account); and
|
|
• |
tangible property and equipment belonging to the Company (whether or not containing or comprising Confidential Information), including in particular, but not limited to,
laptop computers, devices, storage media, keys, pass cards, identification cards, solutions, samples, models, marketing materials, brochures, purchase order forms and letterhead, and all reproductions and copies of such things.
|
|
5. |
Assignment of Inventions; Disclosure and License of Prior Inventions; Work Product
Ownership.
|
|
6. |
Further Assurances. During and after my Employment, upon the request and at
the expense of the Company, I shall execute and deliver any and all documents and instruments, and do such other acts that may be necessary or desirable to evidence the assignment and transfer described in Section 5. I shall do the same to
enable the Company to secure its sole and exclusive rights in the Inventions, Works and related intellectual property rights, or to apply for, prosecute and enforce intellectual property rights with respect to any Inventions or Works, or to
obtain any extension, validation, re-issue, continuance or renewal of any such Intellectual Property Right, in each case in any and all jurisdictions. I agree to disclose to the Company all pertinent information and data with respect to
Inventions, Works and related intellectual property rights. In the event my Employment is terminated, I shall do all the things described in this paragraph without charge to the Company other than a reasonable payment for my time involved.
|
|
7. |
Non-Competition.
|
|
8. |
Non-Solicitation.
|
|
• |
solicit, hire, recruit or attempt to persuade any person to terminate or materially diminish such person’s employment with or engagement by the Company, regardless of
whether or not such person is an employee or contractor, whether such person is full-time or part-time, whether or not such employment is pursuant to a written agreement or is at-will, and whether I initiated the discussion or sought out the
contact; or
|
|
• |
solicit, contact or attempt to persuade any current or prospective customer of the Company to terminate or materially alter such customer’s or prospective customer’s
relationship with the Company; or
|
|
• |
solicit or assist in the solicitation of any current or prospective customer to induce or attempt to induce any such customer or prospective customer to purchase or
contract for any Competing Services. I understand that “prospective customer” means any prospective customer of the Company with whom I had contact at any time during the twelve (12) months preceding the termination of my Employment.
|
|
9. |
Non-Disparagement. At all times, both during and after my Employment, I agree
to refrain from taking any action, or making any statement (oral or written) that disparages or criticizes the Company or its officers, directors, or employees, in any manner that causes, or is reasonably likely to cause, harm to the Company’s
relationship with its existing or potential suppliers, vendors, customers, investors, employees, contractors, or any other persons or entities with whom Company engages in business. I understand that this provision does not apply to Protected
Activities.
|
|
10. |
Duration; Nature. This Agreement is binding during my Employment and shall
survive any termination of my Employment. This Agreement does not bind the Company or me to any specific period of employment and shall not be construed in any manner as an employment agreement or to make my employment other than terminable at
will at any time by the Company in its sole discretion.
|
|
11. |
No Conflicts. I am not a party to any existing agreement that would prevent me
from entering into and performing this Agreement in accordance with its terms, including, without limitation, to an obligation to assign my Inventions, Works or any related intellectual property rights to a third party or any agreement
subjecting me to a non-compete, except as identified in Attachment A hereto; and I will not enter into any other agreement that is in conflict with my
obligations under this Agreement.
|
|
12. |
Disclosure of Obligations. I consent to the Company’s notification to any
third party of the existence and content of this Agreement.
|
|
13. |
Equitable Relief. I agree that the provisions of this Agreement are reasonably
necessary to protect the Company’s legitimate business interests. I agree that it would be impossible or inadequate to measure and calculate the Company’s damages from any breach of the covenants set forth in this Agreement, and that a breach
of such covenants could cause serious and irreparable injury to the Company. Accordingly, the Company shall have available, in addition to any other right or remedy available to it, the right to seek an injunction from a court of competent
jurisdiction restraining such a breach (or threatened breach) and to specific performance of this Agreement. I further agree that no bond or other security shall be required in obtaining such equitable relief and I hereby consent to the
issuance of such injunction and to the ordering of specific performance.
|
|
14. |
No License. Nothing in this Agreement shall be deemed to constitute the grant
of any license or other right to me in respect of any Confidential Information, Invention, Work, related intellectual property right or other data or intellectual property of the Company.
|
|
15. |
Amendment and Assignment. No modification to any provision of this Agreement
will be binding unless it is in writing and signed by both an authorized representative of the Company and me. No waiver of any rights under this Agreement will be effective unless in writing signed by an authorized representative of the
Company. I recognize and agree that my obligations under this Agreement are of a personal nature and are not assignable or delegable in whole or in part by me. The Company may assign this Agreement to any affiliate or to any
successor-in-interest (whether by sale of assets, sale of stock, merger or other business combination). All of the terms and provisions of this Agreement shall be binding upon and inure to the benefit of and be enforceable by the respective
heirs, executors, administrators, legal representatives, successors and permitted assigns of the Company and me.
|
|
16. |
Severability. If any provision of this Agreement or its application is
adjudicated to be invalid or unenforceable in any jurisdiction, such invalidity or unenforceability (a) shall not affect any other provision or application of this Agreement that can be given effect without the invalid or unenforceable
provision or application and shall not invalidate or render unenforceable such provision or application in any other jurisdiction and (b) shall be limited or excluded from this Agreement to the minimum extent required so that this Agreement
shall otherwise remain in full force and effect and enforceable in accordance with its terms. For the avoidance of doubt, if this Agreement is or becomes subject to any state or federal law affecting the Company’s rights with respect to any of
my obligations under this Agreement, this Agreement shall be deemed amended to the extent necessary to comply with such law.
|
|
17. |
Headings; Construction. The headings used in this Agreement have been inserted
for convenience of reference only and do not define or limit the provisions hereof. The Attachments to this Agreement are incorporated herein by reference and shall be deemed a part of this Agreement.
|
|
18. |
Governing Law; Jurisdiction. This Agreement shall be governed by and
interpreted in accordance with laws of the of the State of Delaware without giving effect to any conflict of laws provisions, except matters
of intellectual property law which shall be determined in accordance with the intellectual property laws relevant to the intellectual property in question. I consent to personal jurisdiction of the state and federal courts located in the State of Delaware for any lawsuit filed there against me by the Company arising from or related to this Agreement, to the exclusion of all
other courts, and I accept service of process by registered or certified mail to the address set forth above (or to such other address that I provide to the Company) as if I were personally served within the State of Delaware.
|
March 1, 2024
|
Signature: |
|
|||
Printed Name: |
Stephan F. Toutain, MS, MBA
|
||||
|
|||||
|
|||||
RECEIPT ACKNOWLEDGED
|
|||||
AND ACCEPTED:
|
|
|
|||
|
|
|
|||
PDS BIOTECHNOLOGY CORPORATION
|
|
|
|||
|
|
|
|||
By: |
|
||||
Name: |
Frank Bedu-Addo, PhD
|
||||
Title: |
President & CEO
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of PDS Biotechnology Corporation for the period ended March 31, 2024;
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such
statements were made, not misleading with respect to the period covered by this report;
|
3 |
Based on my knowledge, the condensed consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control
over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant,
including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of condensed consolidated financial statements for external purposes in accordance with generally accepted accounting principles;
|
c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of
the period covered by this report based on such evaluation; and
|
d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably
likely to materially affect, the registrant’s internal control over financial reporting; and
|
5. |
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the
registrant’s board of directors (or persons performing the equivalent functions):
|
a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information; and
|
b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Dated: May 15, 2024
|
/s/ Frank Bedu-Addo
|
|
Frank Bedu-Addo, Ph.D.
|
||
President and Chief Executive Officer
|
||
(Principal Executive Officer)
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of PDS Biotechnology Corporation for the period ended March 31, 2024;
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such
statements were made, not misleading with respect to the period covered by this report;
|
3 |
Based on my knowledge, the condensed consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control
over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant,
including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of condensed consolidated financial statements for external purposes in accordance with generally accepted accounting principles;
|
c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of
the period covered by this report based on such evaluation; and
|
d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably
likely to materially affect, the registrant’s internal control over financial reporting; and
|
5. |
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the
registrant’s board of directors (or persons performing the equivalent functions):
|
a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information; and
|
b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Dated: May 15, 2024
|
/s/ Lars Boesgaard
|
|
Lars Boesgaard
|
||
Chief Financial Officer
|
||
(Principal Financial and Accounting Officer)
|
(1)
|
the Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2) |
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Dated: May 15, 2024
|
/s/ Frank Bedu-Addo
|
|
Frank Bedu-Addo, Ph.D.
|
||
President and Chief Executive Officer
|
||
(Principal Executive Officer)
|
(1) |
the Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2) |
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Dated: May 15, 2024
|
/s/ Lars Boesgaard
|
|
Lars Boesgaard
|
||
Chief Financial Officer
|
||
(Principal Financial and Accounting Officer)
|